Members Mark Cetirizine

Dosage Form: tablet
Sam's West, Inc. Cetirizine Hydrochloride Tablets, 10 mg Drug Facts

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:

• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat

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

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

• do not use if printed foil under cap is broken or missing


• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions or comments?

1-800-809-0469

Principal Display Panel

Original Prescription Strength

Cetirizine

Hydrochloride Tablets, 10 mg/Antihistamine

Allergy

Compare to Zyrtec® active ingredient

24 Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

Indoor & Outdoor Allergies

Actual Size

Cetirizine Hydrochloride Tablets, 10 mg Stretch Pack

Members Mark Cetirizine  cetirizine hydrochloride  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68196-458 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 No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape OVAL Size 10mm Flavor Imprint Code 4H2 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68196-458-03 1 BOTTLE In 1 PACKAGE contains a BOTTLE 1 350 TABLET In 1 BOTTLE This package is contained within the PACKAGE (68196-458-03)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	03/24/2008

Labeler - Sam's West Inc (051957769)

Revised: 05/2009Sam's West Inc

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