ZYRTEC ALLERGY- cetirizine hydrochloride capsule, liquid filled 
Johnson & Johnson Consumer Inc.

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ZYRTEC Allergy

Drug Facts

Active ingredient (in each capsule)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Uses

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

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 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

Other information

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 50580-786-12

ZYRTEC ®

ALLERGY

INDOOR + OUTDOOR

ALLERGIES

Cetirizine HCl/

antihistamine

10 mg capsules

LIQUID

GELS

24

HOUR

RELIEF OF

(Actual Size)

12

LIQUID GELS*


*LIQUID-FILLED CAPSULES

10 mg each

zyrtec-1

ZYRTEC ALLERGY 
cetirizine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-786
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 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
Colorwhite (Clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code CZ10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-786-121 in 1 PACKAGE04/15/2024
112 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-786-251 in 1 PACKAGE04/15/2024
225 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:50580-786-401 in 1 PACKAGE04/15/2024
340 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:50580-786-6565 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21310504/15/2024
Labeler - Johnson & Johnson Consumer Inc. (878046358)

Revised: 1/2024
Document Id: 0fad0744-3bda-35de-e063-6294a90ad9f1
Set id: 0face45c-af24-3559-e063-6294a90abde5
Version: 1
Effective Time: 20240124
 
Johnson & Johnson Consumer Inc.