CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
Rebel Distributors Corp

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Cetirizine Drug Facts

Active ingredient

(in each tablet)

Cetirizine HCl 10 mg

Purpose

Antihistamine

Keep out of reach of children

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

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 an allergic reactions 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.

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

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

Inactive ingredients

Corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate, povidone and titanium dioxide.

Questions? 1-800-525-8747

Manufactured in India by Sandoz Private Ltd.,

for Sandoz Inc., Princeton, NJ 08540

Rev.02/2008

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

NDC 21695-709-14 Bottle of 14

NDC 21695-709-20 Bottle of 20

NDC 21695-709-30 Bottle of 30

Cetirizine HCl Tablets

10 mg

antihistamine

Do not use if individual blister unit is open or torn

ALLERGY

Indoor & Outdoor Allergies

24 hour Relief of

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

CETIRIZINE HYDROCHLORIDE  cetirizine hydrochloride   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 21695-709 (0781-1684) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN   HYPROMELLOSES   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POVIDONE   TITANIUM DIOXIDE   POLYETHYLENE GLYCOL

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (round shape) Size 8mm Flavor Imprint Code SZ;906 Contains

Packaging # NDC Package Description Multilevel Packaging 1 21695-709-14 14 TABLET In 1 BOTTLE None 2 21695-709-20 20 TABLET In 1 BOTTLE None 3 21695-709-30 30 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077946	12/27/2007

Labeler - Rebel Distributors Corp (118802834)

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

Revised: 02/2011Rebel Distributors Corp