CETIRIZINE HYDROCHLORIDE- cetirizine tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Cetirizine HCl 5 mg

PURPOSE

Antihistamine

INDICATIONS AND USAGE

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease.  Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

● drowsiness may occur

● avoid alcoholic drink

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

STOP USE

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding :

if breast-feeding: not recommended

if pregnant: ask a health professional

before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE AND ADMINISTRATION

• Adults andchildren 6years andover: 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
• Adults 65years andover: 1 tablet once a day; do not take more than 1 tablet in 24 hours.
• Childrenunder 6 yearsof age: ask a doctor
• Consumerswith liver orkidneydisease: ask a doctor

OTHER INFORMATION

Other information

store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

OTC - QUESTIONS

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM-5PM EST

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 01-2009

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-045
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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	6mm
Flavor		Imprint Code	IP;45
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-045-03	1 in 1 CARTON
1		30 in 1 BOTTLE
2	NDC: 65162-045-50	500 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078780	01/21/2010

Labeler - Amneal Pharmaceuticals (123797875)

Registrant - Amneal Pharmaceuticals (123797875)

Establishment
Name	Address	ID/FEI	Business Operations
Amneal Pharmaceuticals		831227801	ANALYSIS, LABEL, MANUFACTURE, PACK