ZYRTEC ALLERGY- cetirizine hydrochloride tablet, film coated 
JC World Bell Wholesale Co., Inc

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Zyrtec Allergy

Drug Facts

Active ingredient (in each tablet)

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 over

 one 10 mg tablet once daily; do not take more than one 10 mg tablet 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

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

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

Package Labeling:

Label0Label02

ZYRTEC ALLERGY 
cetirizine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-973(NDC:50580-726)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeRECTANGLESize9mm
FlavorImprint Code ZYRTEC;10;MG
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50269-973-0120 in 1 BOX07/27/2018
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01983507/27/2018
Labeler - JC World Bell Wholesale Co., Inc (805257581)
Establishment
NameAddressID/FEIBusiness Operations
JC World Bell Wholesale Co., Inc.805257581repack(50269-973)
Establishment
NameAddressID/FEIBusiness Operations
Kenvue Brands LLC878046358manufacture(50269-973)

Revised: 12/2024
Document Id: 2a95862d-ede9-4215-e063-6394a90ab4e9
Set id: a4146629-57f0-42e0-b905-df364a8a99f5
Version: 2
Effective Time: 20241231
 
JC World Bell Wholesale Co., Inc