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Cetirizine Hydrochloride by Amneal Pharmaceuticals

Medically reviewed on February 22, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Amneal Pharmaceuticals
NDC Code: 65162-045

CETIRIZINE HYDROCHLORIDE TABLETS

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 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 orkidneydiseaseask 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 
cetirizine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-045
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:65162-045-031 BOTTLE (BOTTLE) in 1 CARTON
130 TABLET (TABLET) in 1 BOTTLE
2NDC:65162-045-50500 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

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Further information

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

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