CETIRIZINE- cetirizine liquid 
Rebel Distributors Corp

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Cetirizine HCl Drug Facts

Active ingredient

Cetirizine HCl 5mg

Keep Out of Reach of Children

Uses

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

° runny nose ° sneezing ° itchy, watery eyes ° itching of the nose or throat

Warnings

Do not use if you have ever had a 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Use only with enclosed dosing cup:

Adults and children 6 years and over: 1 teaspoonful (5ml) or 2 teaspoonfuls (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10ml) in 24 hours.

Adults 65 years and over: 1 teaspoonful (5mo) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours.

Children 2 to under 6 years of age:

1/2 teaspoonful (2.5ml) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5mo) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) in 24 hours.

Children under 2 years of age: ask a doctor

Consumers with liver or kidney disease: ask a doctor

Other Information

Do not use if carton is opened, or if printed neckband is broken or missing.

Questions or comments?

Call 1-800-719-9260

Store between 20° to 25°C (68° to 77°F)

Dosing cup should be washed and left to air dry after each use.

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Distributed by:

AmerisourceBergen

Valley Forge, PA 19482-0959

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Cetirizine HCl 1mg/ml

CETIRIZINE 
cetirizine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-878(NDC:24385-188)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-878-04120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07839806/17/2008
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: 5e652955-bce3-4b0a-a754-739712725aaf
Set id: 5e652955-bce3-4b0a-a754-739712725aaf
Version: 1
Effective Time: 20110215
 
Rebel Distributors Corp