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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 Aug 24, 2023.

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Indications and Usage for Zyrtec Capsule

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)

Zyrtec Capsule Dosage and Administration

adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Storage and Handling

  • 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

PRINCIPAL DISPLAY PANEL
ZYRTEC
cetirizine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-779
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MANNITOL (UNII: 3OWL53L36A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Coloryellow (Clear) Scoreno score
ShapeOVALSize14mm
FlavorImprint CodeZ10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-779-121 in 1 PACKAGE02/08/2010
112 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-779-251 in 1 PACKAGE02/08/2010
225 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:50580-779-401 in 1 PACKAGE02/08/2010
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:50580-779-6565 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product02/08/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02242902/08/2010
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Frequently asked questions

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