Cetirizine by Rebel Distributors Corp CETIRIZINE liquid

Cetirizine by

Drug Labeling and Warnings

Cetirizine by is a Otc medication manufactured, distributed, or labeled by Rebel Distributors Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Cetirizine HCl 5mg

Keep Out of Reach of Children

PURPOSE

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

INGREDIENTS AND APPEARANCE

CETIRIZINE 
cetirizine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21695-878(NDC: 24385-188)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21695-878-04	120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078398	06/17/2008

Labeler - Rebel Distributors Corp (118802834)

Establishment
Name	Address	ID/FEI	Business Operations
Rebel Distributors Corp		118802834	RELABEL, REPACK