Drug name: Zyrtec Capsule Prescribing Information

Description:

Zyrtec Capsule Prescribing Information

Package insert / product label
Generic name: cetirizine hydrochloride
Dosage form: capsule, liquid filled
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl 10 mg

Purpose

Antihistamine

On This Page
  • Indications and Usage
  • Warnings
  • Dosage and Administration

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if foil inner seal printed with "SAFETY SEAL®" is broken or missing

Inactive ingredients

gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions?

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-779-12

ZYRTEC ®
ALLERGY

INDOOR + OUTDOOR
ALLERGIES

Cetirizine HCl/
antihistamine
10 mg capsules

LIQUID
GELS

24
HOUR
RELIEF OF

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

(Actual Size)

12
LIQUID GELS*

*LIQUID-FILLED CAPSULES
10 mg each

ZYRTEC
cetirizine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-779
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN, UNSPECIFIED
GLYCERIN
MANNITOL
POLYETHYLENE GLYCOL 400
WATER
SODIUM HYDROXIDE
SORBITAN
SORBITOL
Product Characteristics
Color yellow (Clear) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code Z10
Contains
Packaging
# Item Code Package Description
1 NDC:50580-779-12 1 BOTTLE in 1 PACKAGE
1 12 CAPSULE, LIQUID FILLED in 1 BOTTLE
2 NDC:50580-779-25 1 BOTTLE in 1 PACKAGE
2 25 CAPSULE, LIQUID FILLED in 1 BOTTLE
3 NDC:50580-779-40 1 BOTTLE in 1 PACKAGE
3 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
4 NDC:50580-779-65 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022429 02/08/2010
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Frequently asked questions

  • Should cetirizine be taken at bedtime or upon awakening?
  • Can you take antihistamines when pregnant?
  • Is Generic Zyrtec Available?

View more FAQ

More about cetirizine

  • Check interactions
  • Compare alternatives
  • Pricing & coupons
  • Reviews (286)
  • Drug images
  • Latest FDA alerts (1)
  • Side effects
  • Dosage information
  • Patient tips
  • During pregnancy
  • Support group
  • Drug class: antihistamines
  • Breastfeeding

Patient resources

  • Drug Information

Professional resources

  • Prescribing Information
  • Cetirizine (FDA)
  • Cetirizine Oral Solution (FDA)
  • Cetirizine Tablets (FDA)

Other brands

Zyrtec, Aller-Tec, Quzyttir, All Day Allergy, ... +2 more

Related treatment guides

  • Urticaria
  • Allergic Rhinitis
  • Eustachian Tube Dysfunction
  • Physical Urticaria

Medical Disclaimer