CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Rebel Distributors Corp

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Cetirizine HCl, USP 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

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

Cetirizine HCl 10mg

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-138(NDC:51660-939)
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
POVIDONE (UNII: FZ989GH94E)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorwhiteScoreno score
ShapeRECTANGLE (rounded-off) Size9mm
FlavorImprint Code RI52
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42254-138-1414 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2012
Document Id: 296e5977-0e8c-4147-a94d-374eb913ab51
Set id: 296e5977-0e8c-4147-a94d-374eb913ab51
Version: 1
Effective Time: 20120229
 
Rebel Distributors Corp