Cetirizine Tablet Drug Facts

Dosage Form: tablet
Cetirizine Hydrochloride Tablets

Drug Facts:

Active ingredient (in each tablet)

Cetirizine HCl 5 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	1 to 2 tablets once daily depending upon    severity of symptoms; do not take more than    2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than   1 tablet in 24 hours
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

colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

call 1-269-544-2299 weekdays

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL

NDC 13668-029-05

Cetirizine HCl Tablets 5 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour Relief of

• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat

500 Tablets 5 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

CETIRIZINE HYDROCHLORIDE   cetirizine hydrochloride   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 13668-029 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   STARCH, CORN   HYPROMELLOSE 2910 (6 CPS)   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   POLYETHYLENE GLYCOL 400   POVIDONE K30   TALC   TITANIUM DIOXIDE

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (rounded-off,rectangular shaped,film coated tablet) Size 7mm Flavor Imprint Code 5;29 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13668-029-30 30 TABLET In 1 BOTTLE None 2 13668-029-01 100 TABLET In 1 BOTTLE None 3 13668-029-25 250 TABLET In 1 BOTTLE None 4 13668-029-05 500 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079191	04/15/2010

Labeler - Torrent Pharmaceuticals Limited (916488547)

Revised: 07/2010Torrent Pharmaceuticals Limited

More Cetirizine Tablet Drug Facts resources

• Cetirizine Tablet Drug Facts Side Effects (in more detail)
• Cetirizine Tablet Drug Facts Dosage
• Cetirizine Tablet Drug Facts Use in Pregnancy & Breastfeeding
• Drug Images
• Cetirizine Tablet Drug Facts Drug Interactions
• Cetirizine Tablet Drug Facts Support Group
• 73 Reviews for Cetirizine Drug Facts - Add your own review/rating

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