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Cetirizine Hydrochloride Hives Relief

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Amneal Pharmaceuticals
NDC Code: 65162-145

CETIRIZINE HYDROCHLORIDE TABLETS

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 andover1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65years andover1 tablet once a day; do not take more than 1 tablet in 24 hours.
Childrenunder 6 yearsof ageask a doctor
Consumerswith liver orkidney diseaseask 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
CETIRIZINE HYDROCHLORIDE  HIVES RELIEF
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-145
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 
POVIDONE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize6mm
FlavorImprint CodeIP;45
Contains    
Packaging
#Item CodePackage Description
1NDC:65162-145-031 BOTTLE (BOTTLE) in 1 CARTON
130 TABLET (TABLET) in 1 BOTTLE
2NDC:65162-145-50500 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07878001/21/2010
Labeler - Amneal Pharmaceuticals (123797875)
Registrant - Amneal Pharmaceuticals (123797875)
Establishment
NameAddressID/FEIOperations
Amneal Pharmaceuticals831227801ANALYSIS, LABEL, MANUFACTURE, PACK

 
Amneal Pharmaceuticals

← See all Cetirizine Hydrochloride Hives Relief brands

Medically reviewed on Feb 21, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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