Formucare Cetirizine

Dosage Form: tablet
Access Business Group International LLC 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?

1-800-719-9260

Principal Display Panel

Indoor & Outdoor Allergies

Cetirizine Hydrochloride Tablets 10 mg

Antihistamine

Allergy

Original Prescription Strength

24 Hour Relief of:

Runny Nose

Itchy, Watery Eyes

Sneezing

Itchy Throat or Nose

Actual Size

Cetirizine Hydrochloride Tablets 10 mg Carton

Formucare Cetirizine HYDROCHLORIDE  cetirizine hydrochloride  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 10056-458 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 10056-458-39 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (10056-458-39)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078336	07/01/2009

Labeler - Access Business Group International LLC (609682641)

Revised: 05/2009Access Business Group International LLC

More Formucare Cetirizine resources

• Formucare Cetirizine Side Effects (in more detail)
• Formucare Cetirizine Dosage
• Formucare Cetirizine Use in Pregnancy & Breastfeeding
• Drug Images
• Formucare Cetirizine Drug Interactions
• Formucare Cetirizine Support Group
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