Vituz (Oral)

Generic name: cough and cold combinations (oral route) [ hye-droe-KOE-done-bye-TAR-trate, klor-fen-IR-a-meen-MAL-ee-ate ]

Medically reviewed by Drugs.com. Last updated on Jan 30, 2023.

Commonly used brand name(s)

In the U.S.

• Ala-Hist AC
• Ala-Hist DHC
• Alavert-D 12-Hour
• Aldex D
• Alka-Seltzer Plus Cold and Sinus
• AllanVan-S
• Allegra
• Allegra-D
• Aller-Chlor
• Allerx-D
• Allfen CD
• Allres PD
• Amibid LA
• Benadryl
• BPM Pseudo
• Bromcomp HC
• Bromfed-PD
• BroveX CB
• By-Ache
• Canges-HC
• Ceron
• Ceron-DM
• Chlor-Trimeton Nasal Decongestant
• Clarinex-D
• Codimal DH
• Cotab A
• Cotabflu
• Cypex-LA
• Deconamine SR
• Delsym
• Dexphen w/C
• Donatussin DC
• Donnatussin
• D-Tann HC
• EndaCof-DC
• FluTuss XP
• Genapap Sinus
• G Phen DM
• HC Tussive
• Histex PD
• Humibid DM
• Hycodan
• Hycofenix
• Hydone
• HyTan
• Kie
• Levall 12
• Lusonal
• Maxiflu CD
• Maxiphen CD
• M-End Max D
• Mucinex D
• Nasop
• Notuss-Forte
• Notuss-NX
• Notuss-NXD
• Novahistine DH
• Pancof HC
• Pediatex 12
• Pediatex 12D
• Pediatex 12DM
• Pediatex-D
• Phenergan w/Codeine
• Phenflu CD
• Phenylephrine CM
• Phenylhistine
• Poly-Tussin AC
• Poly-Tussin DHC
• Pro-Clear AC
• Promethazine VC With Codeine
• Pro-Red AC
• RelaTuss HC
• Robitussin
• Robitussin DM
• Ryneze
• Semprex-D
• SSKI
• Stahist
• Sudafed
• SymTan
• SymTan A
• Tanafed DMX
• Tannate Pediatric
• Tessalon Perles
• Triacin C
• Tricold Pediatric Drops
• Tripohist D
• Tussi-12 S
• TussiCaps
• Tuzistra XR
• Tylenol
• Uni-Tann D
• Vituz
• Xpect-PE
• Xyzal
• Y-Cof DM
• Z-COF DM
• Zhist
• Zodryl DAC 25
• Zotex-D
• Zymine
• Zymine HC
• ZyrTEC-D

In Canada

• Actifed Sinus Regular
• Adult Nighttime Cold/Flu Relief - Cherry Flavor
• Adult Nighttime Cold/Flu Relief - Original Flavor
• Allergy Sinus Medication Extra Strength
• Atoma Night Adult Cold/Flu Relief
• Atoma Nighttime Cold/Flu Relief - Cherry Flavor
• Balminil
• Balminil Dm Children
• Balminil Dm Sugar-Free
• Balminil Expectorant
• Balminil Expectorant Sugar-Free
• Balminil With Sugar

Available Dosage Forms:

• Solution
• Tablet, Chewable
• Tablet, Extended Release, 24 HR
• Tablet, Extended Release
• Tablet, Extended Release, 12 HR
• Tablet
• Syrup
• Liquid
• Capsule, Liquid Filled
• Capsule
• Elixir
• Suspension, Extended Release
• Lozenge/Troche
• Suspension
• Tablet, Effervescent
• Packet
• Powder for Solution
• Film

Uses for Vituz

Cough/cold combinations are used mainly to relieve the cough due to colds, influenza, or hay fever. They are not to be used for the chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Cough/cold combination products contain more than one ingredient. For example, some products may contain an antihistamine, a decongestant, and an analgesic, in addition to a medicine for coughing. If you are treating yourself, it is important to select a product that is best for your symptoms. Also, in general, it is best to buy a product that includes only those medicines you really need. If you have questions about which product to buy, check with your pharmacist.

Since different products contain ingredients that will have different precautions and side effects, it is important that you know the ingredients of the medicine you are taking. The different kinds of ingredients that may be found in cough/cold combinations include:

Antihistamines—Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Some examples of antihistamines contained in these combinations are:

• Bromodiphenhydramine
• Brompheniramine
• Carbinoxamine
• Chlorpheniramine
• Dexchlorpheniramine
• Diphenhydramine
• Doxylamine
• Phenindamine
• Pheniramine
• Phenyltoloxamine
• Pyrilamine
• Promethazine
• Triprolidine

Decongestants—Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion. However, this effect may also increase blood pressure in patients who have high blood pressure. These include:

• Ephedrine
• Phenylephrine
• Pseudoephedrine

Antitussives—Antitussives help relieve coughing and are some contain a narcotic. These antitussives act directly on the cough center in the brain. Narcotics may become habit-forming, causing mental or physical dependence, if used for a long time. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

Narcotic antitussives
• Codeine
• Dihydrocodeine
• Hydrocodone
• Hydromorphone

Non-narcotic antitussives
• Carbetapentane
• Caramiphen
• Dextromethorphan

Expectorants—Expectorants work by loosening the mucus or phlegm in the lungs. The main expectorant used in cough and cold medicines is guaifenesin. Other ingredients added as expectorants (for example, ammonium chloride, calcium iodide, iodinated glycerol, ipecac, potassium guaiacolsulfonate, potassium iodide, and sodium citrate) have not been proven to be effective. In general, the best thing you can do to loosen mucus or phlegm is to drink plenty of water.

Analgesics—Analgesics are used in these combination medicines to help relieve the aches and pain that may occur with the common cold. These include:

• Acetaminophen
• Aspirin
• Other salicylates such as salicylamide and sodium salicylate

The use of too much acetaminophen and salicylates at the same time may cause kidney damage or cancer of the kidney or urinary bladder. This may occur if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

Anticholinergics—Anticholinergics, such as homatropine may help produce a drying effect in the nose and chest.

These cough and cold combinations are available both over-the-counter (OTC) and with your doctor''s prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before using Vituz

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Very young children are usually more sensitive to the effects of this medicine. Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children. If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional, especially if it contains:

• Antihistamines—Nightmares, unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children taking antihistamines.
• Decongestants (e.g., ephedrine, phenylephrine, pseudoephedrine—Increases in blood pressure may be more likely to occur in children taking decongestants.
• Iodides (e.g., calcium iodide and iodinated glycerol)—These medicines pass into the breast milk and may cause unwanted effects, such as underactive thyroid, in the baby.
• Narcotic antitussives (e.g., codeine, dihydrocodeine, hydrocodone, and hydromorphone)—Breathing problems may be especially likely to occur in children younger than 2 years of age taking narcotic antitussives. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines.
• Salicylates (e.g., aspirin)—Do not give medicines containing aspirin or other salicylates to a child or teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child''s doctor. This is very important because salicylates may cause a serious illness called Reye''s syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Also, children may be more sensitive to the aspirin or other salicylates contained in some of these medicines, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

The elderly are usually more sensitive to the effects of this medicine, especially if it contains:

• Antihistamines—Confusion, difficult or painful urination, dizziness, drowsiness, feeling faint, or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly taking antihistamines.
• Decongestants (e.g., ephedrine, phenylephrine, pseudoephedrine—Confusion, hallucinations, drowsiness, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, increases in blood pressure may be more likely to occur in elderly persons taking decongestants.

Pregnancy

The occasional use of a cough/cold combination is not likely to cause problems in the fetus or in the newborn baby. However, when these medicines are used at higher doses and/or for a long time, the chance that problems might occur may increase. For the individual ingredients of these combinations, the following information should be considered before you decide to use a particular cough/cold combination:

• Acetaminophen—Studies on birth defects have not been done in humans. However, acetaminophen has not been shown to cause birth defects or other problems in humans.
• Alcohol—Some of these combination medicines contain a large amount of alcohol. Too much use of alcohol during pregnancy may cause birth defects.
• Antihistamines—Antihistamines have not been shown to cause problems in humans.
• Caffeine—Studies in humans have not shown that caffeine causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine contained in 12 to 24 cups of coffee a day).
• Codeine—Although studies on birth defects with codeine have not been done in humans, it has not been reported to cause birth defects in humans. Codeine has not been shown to cause birth defects in animal studies, but it caused other unwanted effects. Also, regular use of narcotics during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. In addition, narcotics may cause breathing problems in the newborn baby if taken by the mother just before delivery.
• Hydrocodone—Although studies on birth defects with hydrocodone have not been done in humans, it has not been reported to cause birth defects in humans. However, hydrocodone has been shown to cause birth defects in animals when given in very large doses. Also, regular use of narcotics during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. In addition, narcotics may cause breathing problems in the newborn baby if taken by the mother just before delivery.
• Iodides (e.g., calcium iodide and iodinated glycerol)—Not recommended during pregnancy. Iodides have caused enlargement of the thyroid gland in the fetus and resulted in breathing problems in newborn babies whose mothers took iodides in large doses for a long period of time.
• Phenylephrine—Studies on birth defects with phenylephrine have not been done in either humans or animals.
• Pseudoephedrine—Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects but did cause a decrease in average weight, length, and rate of bone formation in the animal fetus when given in high doses.
• Salicylates (e.g., aspirin)—Studies on birth defects in humans have been done with aspirin, but not with salicylamide or sodium salicylate. Salicylates have not been shown to cause birth defects in humans. However, salicylates have been shown to cause birth defects in animals.

Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn''s weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn baby.

Use of salicylates, especially aspirin, during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn baby. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

Breastfeeding

If you are breastfeeding, the chance that problems might occur depends on the ingredients of the combination. For the individual ingredients of these combinations, the following apply:

• Acetaminophen—Acetaminophen passes into the breast milk. However, it has not been reported to cause problems in nursing babies.
• Alcohol—Alcohol passes into the breast milk. However, the amount of alcohol in recommended doses of this medicine does not usually cause problems in nursing babies.
• Antihistamines—Small amounts of antihistamines pass into the breast milk. Antihistamine-containing medicine is not recommended for use while breastfeeding since most antihistamines are especially likely to cause side effects, such as unusual excitement or irritability, in the baby. Also, since antihistamines tend to decrease the secretions of the body, the flow of breast milk may be reduced in some patients.
• Caffeine—Small amounts of caffeine pass into the breast milk and may build up in the nursing baby. However, the amount of caffeine in recommended doses of this medicine does not usually cause problems in nursing babies.
• Codeine and other narcotic cough medicines (e.g., dihydrocodeine, hydrocodone, and hydromorphone)—Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects. A nursing mother should talk to her doctor if she has any questions about taking codeine or about how this medicine may affect her baby .
• Decongestants (e.g., ephedrine, phenylephrine, pseudoephedrine—Phenylephrine has not been reported to cause problems in nursing babies. Ephedrine and pseudoephedrine pass into the breast milk and may cause unwanted effects in nursing babies (especially newborn and premature babies).
• Iodides (e.g., calcium iodide and iodinated glycerol)—These medicines pass into the breast milk and may cause unwanted effects, such as underactive thyroid, in the baby.
• Salicylates (e.g., aspirin)—Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Abrocitinib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amprenavir
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bepridil
• Boceprevir
• Buprenorphine
• Buserelin
• Cabotegravir
• Calcium Oxybate
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Cisapride
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clorgyline
• Clothiapine
• Clozapine
• Cobicistat
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Dasabuvir
• Dasatinib
• Defibrotide
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dichlorphenamide
• Dihydroergotamine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doravirine
• Doxepin
• Dronedarone
• Droperidol
• Ebastine
• Efavirenz
• Elvitegravir
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Fluvoxamine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Furazolidone
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indinavir
• Influenza Virus Vaccine, Live
• Inotuzumab Ozogamicin
• Iproniazid
• Isocarboxazid
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Ketorolac
• Lapatinib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levoketoconazole
• Levomethadyl
• Linezolid
• Lofexidine
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Maraviroc
• Mavacamten
• Mefloquine
• Mesoridazine
• Methadone
• Methotrimeprazine
• Methylene Blue
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moclobemide
• Moricizine
• Moxifloxacin
• Nafarelin
• Nalmefene
• Naltrexone
• Nefazodone
• Nelfinavir
• Nialamide
• Nilotinib
• Nirmatrelvir
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ombitasvir
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Pargyline
• Paritaprevir
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenelzine
• Pimavanserin
• Pimozide
• Pipamperone
• Piperaquine
• Pitolisant
• Ponesimod
• Posaconazole
• Potassium Citrate
• Potassium Oxybate
• Praziquantel
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Rasagiline
• Ribociclib
• Rilpivirine
• Riociguat
• Risperidone
• Ritonavir
• Safinamide
• Samidorphan
• Saquinavir
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sparfloxacin
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tenofovir Alafenamide
• Tetrabenazine
• Thioridazine
• Tipranavir
• Toloxatone
• Tolterodine
• Toremifene
• Tranylcypromine
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Viloxazine
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Ziprasidone
• Zolmitriptan
• Zotepine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abciximab
• Acarbose
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Acepromazine
• Acetazolamide
• Acetyldigoxin
• Adagrasib
• Adenosine
• Alefacept
• Alfentanil
• Alipogene Tiparvovec
• Almotriptan
• Alprazolam
• Alteplase, Recombinant
• Amifampridine
• Amiloride
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Amtolmetin Guacil
• Amygdalin
• Anagrelide
• Ancrod
• Anileridine
• Anisindione
• Antithrombin III Human
• Apixaban
• Aprepitant
• Aprobarbital
• Ardeparin
• Argatroban
• Aripiprazole
• Armodafinil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Atazanavir
• Atogepant
• Avacopan
• Avapritinib
• Axitinib
• Baclofen
• Balsalazide
• Bemiparin
• Bendroflumethiazide
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Betamethasone
• Betrixaban
• Bisacodyl
• Bismuth Subsalicylate
• Bivalirudin
• Boceprevir
• Bosentan
• Brigatinib
• Bromazepam
• Bromfenac
• Bromocriptine
• Bromopride
• Bromperidol
• Brompheniramine
• Bucindolol
• Budesonide
• Bufexamac
• Bumetanide
• Bupivacaine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butalbital
• Butorphanol
• Calcifediol
• Calcium Oxybate
• Cangrelor
• Cannabidiol
• Caplacizumab-yhdp
• Capmatinib
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carmustine
• Carphenazine
• Carteolol
• Carvedilol
• Celecoxib
• Ceritinib
• Certoparin
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorpropamide
• Chlortetracycline
• Chlorthalidone
• Chlorzoxazone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clonixin
• Clopamide
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cobimetinib
• Cocaine
• Codeine
• Conivaptan
• Cortisone
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Daclatasvir
• Dalteparin
• Danaparoid
• Dantrolene
• Daridorexant
• Darunavir
• Dasabuvir
• Deferasirox
• Deferoxamine
• Defibrotide
• Deflazacort
• Delafloxacin
• Delavirdine
• Demeclocycline
• Dermatan Sulfate
• Desipramine
• Desirudin
• Deslanoside
• Desmopressin
• Desogestrel
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Diazoxide
• Dibenzepin
• Dichloralphenazone
• Diclofenac
• Dicumarol
• Dienogest
• Difenoxin
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dihydroartemisinin
• Dihydrocodeine
• Dilevalol
• Diltiazem
• Dinoprostone
• Diphenhydramine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Dixyrazine
• Dolasetron
• Dolutegravir
• Domperidone
• Donepezil
• Dothiepin
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Doxycycline
• Doxylamine
• Dronedarone
• Droperidol
• Drospirenone
• Droxicam
• Duloxetine
• Duvelisib
• Edoxaban
• Efavirenz
• Elbasvir
• Eletriptan
• Encorafenib
• Enflurane
• Enoxacin
• Enoxaparin
• Entacapone
• Entrectinib
• Enzalutamide
• Epinephrine
• Eplerenone
• Epoprostenol
• Eptifibatide
• Eravacycline
• Erdafitinib
• Ergonovine
• Erlotinib
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Estradiol
• Eszopiclone
• Ethacrynic Acid
• Ethchlorvynol
• Ethinyl Estradiol
• Ethopropazine
• Ethylmorphine
• Ethynodiol
• Etintidine
• Etodolac
• Etofenamate
• Etonogestrel
• Etoricoxib
• Etravirine
• Fedratinib
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Feverfew
• Fexinidazole
• Fexofenadine
• Finerenone
• Flibanserin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flunitrazepam
• Fluocortolone
• Fluoxetine
• Fluphenazine
• Flurazepam
• Flurbiprofen
• Fluspirilene
• Fluvoxamine
• Fondaparinux
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Ginkgo
• Givosiran
• Glasdegib
• Glimepiride
• Glipizide
• Glucagon
• Glyburide
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gossypol
• Granisetron
• Grazoprevir
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Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice
• Tobacco

Other medical problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of)—Acetaminophen-containing medicines increase the chance of liver damage; also, some of the liquid medicines contain a large amount of alcohol.

• Anemia or
• Gout or
• Hemophilia or other bleeding problems or
• Stomach ulcer or other stomach problems—These conditions may become worse if you are taking a combination medicine containing aspirin or another salicylate.

• Brain disease or injury or
• Colitis or
• Convulsions (seizures) (history of) or
• Diarrhea or
• Gallbladder disease or gallstones—These conditions may become worse if you are taking a combination medicine containing codeine, dihydrocodeine, hydrocodone, or hydromorphone

• Cystic fibrosis (in children)—Side effects of iodinated glycerol may be more likely in children with cystic fibrosis.

• Diabetes mellitus (sugar diabetes)—Decongestants may put diabetic patients at greater risk of having heart or blood vessel disease.

• Emphysema, asthma, or chronic lung disease (especially in children)—Salicylate-containing medicine may cause an allergic reaction in which breathing becomes difficult.

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Some of the effects of anticholinergics (e.g., homatropine) or antihistamines may make urinary problems worse.

• Glaucoma—A slight increase in inner eye pressure may occur with the use of anticholinergics (e.g., homatropine) or antihistamines, which may make the condition worse.

• Heart or blood vessel disease or
• High blood pressure—Decongestant-containing medicine may increase the blood pressure and speed up the heart rate; also, caffeine-containing medicine, if taken in large amounts, may speed up the heart rate.

• Kidney disease—This condition may increase the chance of side effects of this medicine because the medicine may build up in the body.

• Liver disease—Liver disease increases the chance of side effects because the medicine may build up in the body; also, if liver disease is severe, there is a greater chance that aspirin-containing medicine may cause bleeding.

• Thyroid disease—If an overactive thyroid has caused a fast heart rate, the decongestant in this medicine may cause the heart rate to speed up further; also, if the medicine contains narcotic antitussives (e.g., codeine), iodides (e.g., iodinated glycerol), or salicylates, the thyroid problem may become worse.

Proper use of Vituz

This section provides information on the proper use of a number of products that contain cough and cold combinations. It may not be specific to Vituz. Please read with care.

To help loosen mucus or phlegm in the lungs, drink a glass of water after each dose of this medicine, unless otherwise directed by your doctor.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

For patients taking the extended-release capsule or tablet form of this medicine:

• Swallow the capsule or tablet whole.
• Do not crush, break, or chew before swallowing.
• If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

For patients taking the extended-release oral solution or oral suspension form of this medicine:

• Do not dilute with fluids or mix with other drugs.

For patients taking a combination medicine containing an antihistamine and/or aspirin or other salicylate:

• Take with food or a glass of water or milk to lessen stomach irritation, if necessary.

If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing. Do not refrigerate the syrup.

Precautions while using Vituz

If your cough has not improved after 7 days or if you have a high fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

• Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic cough medicine (dihydrocodeine, hydrocodone, or hydromorphone):

• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

For patients taking antihistamine-containing medicine:

• Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.
• This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
• This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally.
• Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.
• When taking antihistamines on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin at the same time (as in arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by the antihistamine.
• Antihistamines may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

For patients taking decongestant-containing medicine:

• This medicine may add to the central nervous system (CNS) stimulant effects of diet aids. Do not use medicines for diet or appetite control while taking this medicine unless you have checked with your doctor.
• This medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing medicine:

• This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
• This medicine may cause some people to become drowsy, dizzy, less alert than they are normally, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.
• Nausea or vomiting may occur after taking a narcotic antitussive. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your doctor.
• Dizziness, lightheadedness, or fainting may be especially likely to occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.
• Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking iodide (calcium iodide, iodinated glycerol, or potassium iodide)-containing medicine:

• Make sure your doctor knows if you are planning to have any future thyroid tests. The results of the thyroid test may be affected by the iodine in this medicine.

For patients taking analgesic-containing medicine:

• Check the label of all nonprescription (over-the-counter [OTC]), and prescription medicines you now take. If any contain acetaminophen or aspirin or other salicylates, including diflunisal or bismuth subsalicylate, be especially careful. Taking them while taking a cough/cold combination medicine that already contains them may lead to overdose. If you have any questions about this, check with your health care professional.
• Do not take aspirin-containing medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For diabetic patients taking aspirin- or sodium salicylate-containing medicine:

• False urine sugar test results may occur:
  • If you take 8 or more 325-mg doses of aspirin every day for several days in a row.
  • If you take 8 or more 325-mg or 4 or more 500-mg doses of sodium salicylate.
• Smaller doses or occasional use of aspirin or sodium salicylate usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

For patients taking homatropine-containing medicine:

• This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are taking this medicine.

Vituz side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.

Get emergency help immediately if any of the following symptoms of overdose occur:

For narcotic antitussive (codeine, dihydrocodeine, hydrocodone, or hydromorphone)-containing

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Cold, clammy skin
• confusion (severe)
• convulsions (seizures)
• drowsiness or dizziness (severe)
• nervousness or restlessness (severe)
• pinpoint pupils of eyes
• slow heartbeat
• slow or troubled breathing
• Difficulty breathing
• difficulty nursing
• increased sleepiness (more than usual)
• limpness

For acetaminophen-containing

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling or tenderness in the upper abdomen or stomach area

For salicylate-containing

• Any loss of hearing
• bloody urine
• confusion
• convulsions (seizures)
• dizziness or lightheadedness
• drowsiness (severe)
• excitement or nervousness (severe)
• fast or deep breathing
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased sweating
• nausea or vomiting (severe or continuing)
• shortness of breath or troubled breathing (for salicylamide only)
• stomach pain (severe or continuing)
• uncontrollable flapping movements of the hands, especially in elderly patients
• unusual thirst
• vision problems

For decongestant-containing

• Fast, pounding, or irregular heartbeat
• headache (continuing and severe)
• nausea or vomiting (severe)
• nervousness or restlessness (severe)
• shortness of breath or troubled breathing (severe or continuing)

Check with your doctor as soon as possible if any of the following side effects occur:

For all combinations

• Skin rash, hives, and/or itching

For antihistamine- or anticholinergic-containing

• Clumsiness or unsteadiness
• convulsions (seizures
• drowsiness (severe)
• dryness of mouth, nose, or throat (severe)
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• restlessness (severe)
• shortness of breath or troubled breathing
• slow or fast heartbeat

For iodine-containing

• Headache (continuing)
• increased watering of mouth
• loss of appetite
• metallic taste
• skin rash, hives, or redness
• sore throat
• swelling of face, lips, or eyelids

For acetaminophen-containing

• Unexplained sore throat and fever
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decreased sweating
• difficult or painful urination
• dizziness or lightheadedness
• drowsiness
• dryness of mouth, nose, or throat
• false sense of well-being
• increased sensitivity of skin to sun
• nausea or vomiting
• nightmares
• stomach pain
• thickening of mucus
• trouble in sleeping
• unusual excitement, nervousness, restlessness, or irritability
• unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Vituz Oral Solution Prescribing Information

Package insert / product label
Generic name: hydrocodone bitartrate, and chlorpheniramine maleate
Dosage form: oral solution

Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.

Indications and Usage for Vituz Oral Solution

Cough and Upper Respiratory Allergy Symptoms

VITUZ® Oral Solution is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].

Vituz Oral Solution Dosage and Administration

Administer Vituz Oral Solution by the oral route only. Measure Vituz Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.9)].

Adults 18 Years of Age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.

Dosage Forms and Strengths

VITUZ is a clear, colorless to light yellow, grape-flavored liquid.

5 mL of Vituz Oral Solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg [see Description (11)].

Contraindications

Vituz Oral Solution is contraindicated in:

• Patients with known hypersensitivity to hydrocodone bitartrate, chlorpheniramine maleate or any of the inactive ingredients of Vituz Oral Solution.
• Patients receiving MAOI therapy or within 14 days of stopping such therapy.
• Patients with narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease.

Warnings and Precautions

Risks from Concomitant Use with Benzodiazepines or other CNS Depressants

Concomitant use of opioids, including VITUZ, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see Drug Interactions (7.1)].

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if VITUZ is used with benzodiazepines, alcohol, or other CNS depressants [see Patient Counseling Information (17.3)].

Respiratory Depression

Hydrocodone bitartrate, one of the active ingredients of Vituz Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administrating Vituz Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, discontinue Vituz Oral Solution and use naloxone hydrochloride when indicated to antagonize the effect and other supportive measures as necessary [see Overdosage (10)].

Drug Dependence

Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Vituz Oral Solution. Prescribe and administer VITUZ with the same degree of caution appropriate to the use of other opioid drugs [see Drug Abuse and Dependence (9.2, 9.3)].

Head Injury and Increased Intracranial Pressure

The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of Vituz Oral Solution should be avoided in these patients.

Activities Requiring Mental Alertness

Hydrocodone bitartrate and chlorpheniramine maleate, the active ingredients in Vituz Oral Solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Vituz Oral Solution. Concurrent use of Vituz Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.

Acute Abdominal Conditions

Vituz Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus [see Drug Interactions (7.3)].

Co-administration with Anticholinergics

The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using Vituz Oral Solution in patients taking anticholinergic medications [see Drug Interactions (7.3)].

Co-administration with MAOIs or Tricyclic Antidepressants

Vituz Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy. The use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate, one of the active ingredients in Vituz Oral Solution, may increase the effect of either the antidepressant or hydrocodone [see Contraindications (4) and Drug Interactions (7.2)].

Dosing

Patients should be advised to measure Vituz Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions [see Overdosage (10)]. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.

Coexisting Conditions

Vituz Oral Solution should be used with caution in patients with thyroid disease, Addison''s disease, prostatic hypertrophy, urethral stricture, or asthma.

Renal Impairment

Vituz Oral Solution should be used with caution in patients with severe renal impairment [see Use in Specific Populations (8.6)].

Hepatic Impairment

Vituz Oral Solution should be used with caution in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

Adverse Reactions

Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:

• Respiratory depression [see Warnings and Precautions (5.2) and Overdosage (10)]
• Drug dependence [see Warnings and Precautions (5.3)]
• Increased intracranial pressure [see Warnings and Precautions (5.4) and Overdosage (10)]
• Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.5)]
• Paralytic ileus [see Warnings and Precautions (5.6)]

Use of chlorpheniramine, an antihistamine, may result in:

• Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.5)]

The following adverse reactions have been identified either during clinical trials of hydrocodone bitartrate and/or chlorpheniramine maleate or during their use post-approval. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions of Vituz Oral Solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, tremor.

Other adverse reactions include:

Respiratory: Dryness of the pharynx and respiratory passages, occasional tightness of the chest, laryngismus, wheezing, or troubled breathing.

Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, and/or loss of appetite.

Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy.

Dermatological System: Skin rash, pruritus, erythema, urticaria, excessive perspiration.

Drug Interactions

No specific interaction studies have been conducted with Vituz Oral Solution.

Benzodiazepines, Opioids, Antihistamines, Antipsychotics, Anti-anxiety Agents, or Other CNS Depressants (Including Alcohol)

The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with Vituz Oral Solution may cause an additive CNS depressant effect , profound sedation, respiratory depression, coma, and death and should be avoided [see Warnings and Precautions (5.1)].

MAOIs and Tricyclic Antidepressants

Do not prescribe Vituz Oral Solution if the patient is taking a prescription MAOI (i.e., certain drugs used for depression, psychiatric or emotional conditions, or Parkinson''s disease), or for 2 weeks after stopping a MAOI drug. The use of MAOIs or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone [see Warnings and Precautions (5.8)].

Anticholinergic Drugs

Hydrocodone and chlorpheniramine should be administered cautiously to persons receiving other anticholinergic drugs in order to avoid paralytic ileus and excessive anticholinergic effects.

Additive adverse effects resulting from cholinergic blockade (e.g., xerostomia, blurred vision, or constipation) may occur when anticholinergic drugs are administered with chlorpheniramine [see Warnings and Precautions (5.7)].

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category C

There are no adequate and well-controlled studies of Vituz Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with Vituz Oral Solution; however, studies are available with individual active ingredients or related active ingredients. Hydrocodone was teratogenic in hamsters. Codeine, an opiate related to hydrocodone, increased resorptions and decreased fetal weight in rats. A single retrospective study reported that chlorpheniramine was teratogenic in humans; however, the significance of these findings was not known. Developmental toxicity was also evident with chlorpheniramine in mice and rats. Because animal reproduction studies are not always predictive of human response, Vituz Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

Hydrocodone:

Hydrocodone has been shown to be teratogenic in hamsters when given in a dose approximately 35 times the maximum recommended human daily dose (MRHDD) (on a mg/m2 basis at a single subcutaneous dose of 102 mg/kg on gestation day 8). Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 50 times the MRHDD of hydrocodone (on a mg/m2 basis at an oral dose of 120 mg/kg/day of codeine) increased resorptions and decreased fetal weight; however, these effects occurred in the presence of maternal toxicity. In studies in which rabbits and mice were dosed throughout organogenesis, doses of codeine up to approximately 25 and 120 times, respectively, the MRHDD of hydrocodone (on a mg/m2 basis at oral doses of 30 and 600 mg/kg/day, respectively), produced no adverse developmental effects.

Chlorpheniramine:

A retrospective study found a small, but statistically significant, association between maternal use of chlorpheniramine and inguinal hernia and eye or ear anomalies in children. Other retrospective studies have found that the frequency of congenital anomalies, in general, was not increased among offspring of women who took chlorpheniramine during pregnancy. The significance of these findings to the therapeutic use of chlorpheniramine in human pregnancy is not known.

In studies with chlorpheniramine in which pregnant rats and rabbits were dosed throughout organogenesis, oral doses up to approximately 20 and 25 times the MRHDD on a mg/m2 basis, respectively, produced no adverse developmental effects. However, when mice were dosed throughout pregnancy, a dose approximately 5 times the MRHDD (on a mg/m2 basis at an oral dose of 20 mg/kg/day) was embryolethal, and postnatal survival was decreased when dosing was continued after parturition. Embryolethality was also observed when male and female rats were dosed with approximately 5 times the MRHDD (on a mg/m2 basis at an oral dose of 10 mg/kg/day) prior to mating.

Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

Labor and Delivery

As with all opioids, administration of Vituz Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

Caution should be exercised when VITUZ is administered to nursing mothers. Hydrocodone and chlorpheniramine are excreted in human milk. The clinical significance is unknown; however, the anticholinergic action of chlorpheniramine may suppress lactation if taken prior to nursing. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Vituz Oral Solution, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Vituz Oral Solution in pediatric patients under 18 years of age have not been established. The use of hydrocodone in children less than 6 years of age has been associated with fatal respiratory depression [see Warnings and Precautions (5.2)].

Geriatric Use

Clinical studies have not been conducted with Vituz Oral Solution. Other reported clinical experience with the individual active ingredients of Vituz Oral Solution has not identified differences in responses between the elderly and patients younger than 65 years of age. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal Impairment

Vituz Oral Solution should be given with caution in patients with severe impairment of renal function.

Hepatic Impairment

Vituz Oral Solution should be given with caution in patients with severe impairment of hepatic function.

Drug Abuse and Dependence

Controlled Substance

Vituz Oral Solution is a Schedule II controlled prescription containing hydrocodone bitartrate and should be prescribed and administered with caution.

Abuse

Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Vituz Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.

Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Vituz Oral Solution should be prescribed and administered with caution.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

Overdosage

No human overdosage data are available for Vituz Oral Solution.

Hydrocodone:

Overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Chlorpheniramine:

Manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Dry mouth, pharynx, bronchi, and nasal passages may be observed.

Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia.

An adult ingested 400 mg chlorpheniramine with no reported serious adverse effects. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported with accidental overdose of chlorpheniramine.

Treatment of overdosage consists of discontinuation of Vituz Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride.

An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Hemodialysis is not routinely used to enhance the elimination of chlorpheniramine from the body. Urinary excretion of chlorpheniramine is increased when the pH of the urine is acidic; however, acid diuresis is NOT recommended to enhance elimination in overdose, as the risks of acidemia and acute tubular necrosis in patients with rhabdomyolysis far outweigh any potential benefit.

Vituz Oral Solution Description

Vituz Oral Solution contains hydrocodone bitartrate (a semisynthetic centrally-acting opioid antitussive) and chlorpheniramine maleate (an antihistamine).

Each 5 mL dose of Vituz Oral Solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg.

Vituz Oral Solution also contains: citric acid anhydrous, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, and sucrose.

Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:

	Hydrocodone Bitartrate C18H21NO3 ∙ C4H6O6 ∙ 2.5 H2O Molecular weight = 494.5

Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1) and has the following chemical structure:

	Chlorpheniramine Maleate C16H19C1N2 ∙ C4H4O4 Molecular weight = 390.86

Vituz Oral Solution - Clinical Pharmacology

Mechanism of Action

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.

Chlorpheniramine is an antihistamine drug (H1 receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Pharmacokinetics

Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of hydrocodone bitartrate and chlorpheniramine maleate after single dose administration of 5 mL Vituz Oral Solution are equivalent to respective reference solutions of 5 mL hydrocodone bitartrate (5 mg/5 mL), and 5 mL chlorpheniramine maleate (4 mg/5 mL).

Hydrocodone had mean (SD) peak plasma concentration of 10.6 (2.63) ng/mL at 1.4 (0.55) hours. The mean plasma half-life of hydrocodone is approximately 4.9 hours. Chlorpheniramine had a mean (SD) plasma peak concentration of 7.20 (1.98) ng/mL at 3.5 (1.6) hours. The mean plasma half-life of chlorpheniramine is approximately 24 hours.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with Vituz Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.

Hydrocodone:

Carcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 30 and 80 times, respectively, the MRHDD of hydrocodone on a mg/m2 basis).

Chlorpheniramine:

In 2 year studies in F344/N rats and B6C3F1 mice, chlorpheniramine maleate showed no evidence of tumorigenicity when administered 5 days/week at oral doses up to 30 and 50 mg/kg/day, respectively (approximately 15 times the MRHDD on a mg/m2 basis).

Chlorpheniramine maleate was not mutagenic in the in vitro bacterial reverse mutation assay or the in vitro mouse lymphoma forward mutation assay. Chlorpheniramine maleate was clastogenic in the in vitro CHO cell chromosomal aberration assay.

Chlorpheniramine maleate had no effects on fertility in rats and rabbits at oral doses approximately 20 and 25 times the MRHDD on a mg/m2 basis, respectively.

Clinical Studies

Efficacy studies were not conducted with Vituz Oral Solution. Efficacy of Vituz Oral Solution is based on demonstration of bioequivalence to the individual reference products [see Clinical Pharmacology (12.3)].

How Supplied/Storage and Handling

Vituz Oral Solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in:

White HDPE bottles of one pint (480 mL): NDC 63717-877-16

Store solution at 20° to 25°C (68° to 77°F). [USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure.

Patient Counseling Information

Overdosage

Patients should be advised not to increase the dose or dosing frequency of Vituz Oral Solution because serious adverse events such as respiratory depression may occur with overdosage [see Warnings and Precautions (5.2); Overdosage (10)].

Dosing

Patients should be advised to measure Vituz Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose [see Warnings and Precautions (5.9)].

Interactions with Benzodiazepines and Other Central Nervous System Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if Vituz Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of Vituz Oral Solution with benzodiazepines or other CNS depressants, including alcohol [see Warnings and Precautions (5.1), Drug Interactions (7.1)].

Activities Requiring Mental Alertness

Patients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Vituz Oral Solution may produce marked drowsiness [see Warnings and Precautions (5.5)].

Drug Dependence

Patients should be cautioned that Vituz Oral Solution contains hydrocodone bitartrate and can produce drug dependence [see Warnings and Precautions (5.3)].

MAOIs

Patients should be informed that they should not use Vituz Oral Solution with a MAOI or within 14 days of stopping use of an MAOI [see Warnings and Precautions (5.8)].

Manufactured for: Hawthorn Pharmaceuticals, Inc., Morristown, NJ 07960
Vituz Oral Solution is a Registered Trademark of Hawthorn Pharmaceuticals, Inc.

HI279 1/2017

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

NDC 63717-877-16

VITUZ® CII
(Hydrocodone Bitartrate and
Chlorpheniramine Maleate)
Oral Solution

5 mg/4 mg per 5 mL

Contains:

Hydrocodone
Bitartrate
5 mg/5 mL
WARNING: May be habit forming.

Chlorpheniramine
Maleate
4 mg/5 mL

PHARMACIST: Dispense the enclosed
Medication Guide to each patient.

Rx Only

HAWTHORN
PHARMACEUTICALS, INC.

16 fl oz (480 mL)

Medical Disclaimer

Copyright ©2017 Hawthorn Pharmaceuticals, Inc.