7T Gummy ES Chewable Tablets Prescribing Information

Package insert / product label
Generic name: acetaminophen
Dosage form: tablet, chewable

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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

7T Gummy ES (Acetaminophen Chewable Gels 500 mg)

7T Pharma, LLC

----------------

7T Gummy ES Chewable Tablets Description

7T Gummy ES is available as a chewable gel or gummy oral dosage form with improved organoleptic properties of taste, softness, chewiness, hardness, and translucency.

Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

In addition, each chewable gel contains the following inactive ingredients: hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

7T Gummy ES Chewable Tablets - Clinical Pharmacology

Mechanism or Action

The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central nervous system actions.

Pharmacodynamics

Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Pharmacokinetics
Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. A small fraction (10 to 25%) of acetaminophen is bound to plasma proteins. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: conjugation with glucuronide; conjugation with sulfate; and oxidation via the cytochrome, P450-dependent, mixed-function oxidase enzyme pathway to form a reactive intermediate metabolite, which conjugates with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. The principal cytochrome P450 isoenzyme involved appears to be CYP2E1, with CYP1A2 and CYP3A4 as additional pathways. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

Indications and Usage for 7T Gummy ES Chewable Tablets

7T Gummy ES is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.

Warnings

Keep out of reach of children.

Caution is advised for this formulation with extra strength dosing of acetaminophen due to the easily chewable gels and good taste. This is not a candy and the same caution with every medication should be applied to this product.

Hepatotoxicity

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours
  
• with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
  
• 3 or more alcoholic drinks every day while using this product

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Acetaminophen may cause severe skin reactions. Symptoms may include

• skin reddening
  
• blisters
  
• rash

If a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Precautions

This formulation with extra strength acetaminophen should be taken under the supervision of a physician if:

• taking a blood thinning drug called warfarin
  
• you or a family member have a history of high blood pressure or you are taking any antihypertensive medications due to the sodium content in each chewable gel
  
• you or a family member have a history of diabetes or you are taking any diabetes medications due to the sugar content in each chewable gel

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
  
• fever gets worse or lasts more than 3 days
  
• new symptoms occur
  
• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, consult a physician or health professional before use.

Overdosage

Following an acute overdosage, toxicity may result from acetaminophen.

Clinical Presentation:
Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment of Overdose:
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

7T Gummy ES Chewable Tablets Dosage and Administration

Do not take more than directed (see overdose warning)

Adults and children 12 years and over:

• take 2 chewable gels every 6 hours while symptoms last or as prescribed and directed by a physician
  
• chew each chewable gel thoroughly before swallowing
  
• do not take more than 6 chewable gels in 24 hours, unless directed by a physician
  
• under the supervision of a physician, daily doses up to 8 chewable gels may be used
  
• do not take for more than 10 days unless prescribed and directed by a physician

OTHER INFORMATION

• each chewable gel contains: sodium 7.44 mg.
  
• each chewable gel contains: sugar 2g.
  
• store in a cool dry place between 20-25°C (68-77°F).

Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive ingredients: hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

How is 7T Gummy ES Chewable Tablets Supplied

7T Gummy ES is supplied in the following dosage form:

Eight (8) chewable gels per container

Made in USA

Rx Only

Manufactured for:

7T Pharma, LLC

220 Emerald Vista Way

Las Vegas, NV 89144

800.941.2848

NDC: 70645-500-88 Size: 8 Chewable Gels

PRINCIPAL DISPLAY PANEL

NDC 70645-500-88
Rx Only
7T Gummy ES
Acetaminophen 500 mg
Chewable Gels
8 Orange Flavored Gummies
Extra Strength

Frequently asked questions

• What''s the best sore throat medicine to use?
• What medications cause liver enzymes to be elevated?
• Which painkiller should you use?
• Acetaminophen vs Ibuprofen: Which is better?
• What is paracetamol / panadol called in the US?
• How long does Percocet stay in your system?
• Advil (ibuprofen) & Tylenol (acetaminophen) together, is it safe?

Medical Disclaimer

8-Mop

Generic name: methoxsalen (oral) [ meth-OX-a-len ]
Brand names: 8-Mop, Oxsoralen-Ultra
Drug class: Psoralens

Medically reviewed by Drugs.com on Jan 20, 2023. Written by Cerner Multum.

What is 8-Mop?

8-Mop works by enhancing the body''s sensitivity to ultraviolet light A (UVA).

8-Mop is used in combination with UVA light therapy to treat severe psoriasis.

8-Mop can cause harmful effects on your vision and on your skin (premature aging or skin cancer). 8-Mop is used only for severe psoriasis that has not improved with other treatments. You must remain under the care of a doctor while taking this medicine.

8-Mop may also be used for purposes not listed in this medication guide.

Warnings

You should not use 8-Mop if you are sensitive to light, if you have lens damage in your eye, or if you have had skin cancer.

8-Mop can cause harmful effects on your vision and on your skin. You must avoid natural sunlight for up to 48 hours after UVA treatment.

Oxsoralen-Ultra and 8-Mop are not equivalent medicines and may not have the same dosing schedule.

Before taking this medicine

You should not use 8-Mop if you are allergic to 8-Mop or similar medicines, or if you have:

• lupus, porphyria, albinism, or other conditions that make you more sensitive to light;

• a history of skin cancer (melanoma or squamous cell carcinoma); or

• damage to the lenses of your eyes caused by surgery, injury, or genetic condition.

Before your UVA treatment: Do not expose your skin to sunlight for at least 24 hours before you take 8-Mop. Avoid applying sunscreen to areas of psoriasis that will be treated with UVA therapy.

You may need to have your eyes examined before you start taking 8-Mop.

To make sure 8-Mop is safe for you, tell your doctor if you have ever had:

• heart disease;

• liver or kidney disease;

• a skin pigment disorder;

• cataracts;

• basal cell carcinoma;

• extreme sensitivity to sunlight (if you sunburn easily); or

• radiation or x-ray therapy, or treatment with arsenic trioxide (Trisenox).

It is not known whether 8-Mop taken orally will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

How should I take 8-Mop?

You may need to have your eyes examined first.

Follow all directions on your prescription label. Use the medicine exactly as directed.

8-Mop doses are based on weight. Tell your doctor if you gain or lose weight.

You will take 8-Mop a certain number of hours before you are scheduled to receive UVA treatment. Soft gelatin capsules (Oxsoralen-Ultra) are more easily absorbed than hard gelatin capsules (8-Mop). The timing of your dose will depend on the type of capsule you are taking.

You may need to keep taking 8-Mop for a short time after UVA treatment. Follow your doctor''s dosing instructions very carefully.

Take this medicine with low-fat food or milk if it upsets your stomach.

If your doctor changes your brand, strength, or type of methoxsalen, your dose needs and UVA light therapy schedule may change. Oxsoralen-Ultra and 8-Mop are not equivalent medicines and may not have the same dosing schedule.

8-Mop will make you more sensitive to sunlight, which can cause harmful effects on your vision and on your skin (premature aging or skin cancer).

For at least 8 hours after you take 8-Mop:

• Avoid exposure to sunlight or tanning beds.

• Even sunlight shining through clouds or through a glass window can expose you to harmful UV rays.

• Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors or near a window.

• Do not apply sunscreen to areas of active psoriasis that will be treated with UVA therapy.

For 24 to 48 hours after you receive UVA treatment:

• You must protect your skin and eyes from natural sunlight (even sun shining through a window).

• Do not expose your skin to any sunlight. Wear protective clothing including a hat and gloves. Use a sunscreen with a minimum SPF of 30, and apply it to all uncovered skin areas exposed to light.

• Wear sunglasses for at least 24 hours after treatment.

• For utmost protection, wear a pair of wraparound UVA-absorbing sunglasses, even while you are indoors near a window.

You may develop cataracts if you do not properly protect your eyes after 8-Mop and UVA treatment.

Follow your doctor''s instructions about applying topical psoriasis medications or any moisturizing lotions after your 8-Mop and UVA treatment.

Check your skin regularly for signs of skin cancer, such as a small growth or nodule, a scaly or crusted lesion, a brownish spot or speckles, or a change in the size, color, or feel of a mole. You may need to check your skin for signs of cancer throughout the rest of your life.

Store 8-Mop at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Call your doctor for instructions if you did not take 8-Mop at the correct time before your scheduled UVA treatment. You may need to reschedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may be instructed to make yourself vomit and stay in a dark room for 24 hours. You will be extremely sensitive to light after an overdose.

What should I avoid while taking 8-Mop?

Avoid exposure to sunlight or artificial UV rays other than your scheduled light therapy treatments.

8-Mop side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

8-Mop may cause serious side effects. Call your doctor at once if you have:

• severe skin redness within 24 hours after UVA treatment;

• swelling, severe itching, or severe skin discomfort;

• skin redness and swelling with blisters;

• worsening of your psoriasis;

• a new skin lesion, or a mole that has changed in size or color; or

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

Mild skin redness may occur and can last for 1 or 2 days. This is a normal side effect after UVA treatment and may not be a sign of severe sunburn. Ask your doctor if you have concerns about any redness or swelling.

Common side effects of 8-Mop may include:

• itching, redness;

• nausea;

• feeling nervous; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect 8-Mop?

Tell your doctor about all your current medicines and any you start or stop using. 8-Mop can make your skin even more sensitive to sunlight if you also use certain other medicines, especially:

• anthralin;

• an antibiotic or a sulfa drug;

• certain antimicrobial soaps;

• a diuretic or "water pill";

• coal tar applied to the skin or scalp--such as Neutrogena T/Gel, Psoriasin, Tegrin Medicated;

• medicine to treat mental illness--fluphenazine, prochlorperazine, thioridazine, and others; or

• a staining dye--such as methylene blue, toluidine blue, rose bengal, or methyl orange.

This list is not complete. Other drugs may interact with methoxsalen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Further information

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

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 3.01.