CETIRIZINE - cetirizine hydrochloride tablet 
Bryant Ranch Prepack

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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.

Directions

6 years and over

adults and children

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

Other information

Inactive ingredients

corn starch, FD&C blue no. 1, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Cetirizine 10mg Tablet

Label Image

CETIRIZINE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-3708(NDC:45802-919)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
Product Characteristics
ColorWHITEScore no score
ShapeOVALSize10mm
FlavorImprint Code 4H2
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63629-3708-37 TABLET ( TABLET) in 1 BOTTLENone
2NDC:63629-3708-410 TABLET ( TABLET) in 1 BOTTLENone
3NDC:63629-3708-690 TABLET ( TABLET) in 1 BOTTLENone
4NDC:63629-3708-214 TABLET ( TABLET) in 1 BOTTLENone
5NDC:63629-3708-515 TABLET ( TABLET) in 1 BOTTLENone
6NDC:63629-3708-720 TABLET ( TABLET) in 1 BOTTLENone
7NDC:63629-3708-130 TABLET ( TABLET) in 1 BOTTLENone
8NDC:63629-3708-860 TABLET ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07833601/16/2008

Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK, RELABEL

Revised: 05/2009 Bryant Ranch Prepack