CETIRIZINE HYDROCHLORIDE HIVES RELIEF- cetirizine tablet

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals. 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

Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

WARNINGS

Severe Allergy Warning: Get emergency help immediately if you have hives along

with any of the following symptoms:

trouble swallowing

dizziness or loss of consciousness

swelling of tongue

swelling in or around mouth

trouble speaking

drooling

wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

DO NOT USE

Do not use

to prevent hives from any known cause such as:

foods insect stings medicines latex or rubber gloves

because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for medical exam. Your doctor may be able to help you find a cause.

if you have ever had an allergic reaction to this product or 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.

hives that are an unusual color, look bruised or blistered

hives that do not itch

ASK DOCTOR/PHARMACIST

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

STOP USE

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

symptoms do not improve after 3 days of treatment

the hives have lasted more than 6 weeks

WHEN USING

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

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 orkidney disease: 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  HIVES RELIEF
cetirizine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-145
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: 65162-145-03	1 in 1 CARTON
1		30 in 1 BOTTLE
2	NDC: 65162-145-50	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