ZYRTEC- cetirizine hydrochloride capsule, liquid filled 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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ZYRTEC

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 50580-779-12

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

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 Code Z10
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., McNeil Consumer Healthcare Division (878046358)

Revised: 12/2018
Document Id: d7532844-79d8-4648-ab9b-e5d3d3ad76f9
Set id: 605adf29-734f-451a-8ff3-74be7b5814a6
Version: 8
Effective Time: 20181211
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division