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Cetirizine hydrochloride by Granules India Ltd

Medically reviewed on May 29, 2018

Dosage form: tablet, coated
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Granules India Ltd
NDC Code: 62207-764

Cetrizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets

Drug Facts

Active Ingredient

Cetirizine HCl 10 mg

PURPOSE

Antihistamine

USE(S)

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

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

liver or kidney disease. Your doctor should determine if you need a different dose.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

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 DOCTOR IF

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

PREGNANCY/BREASTFEEDING
  • 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. (1-800-222-1222)

DIRECTIONS
adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

STORAGE
  • store between 20° to 25°C (68° to 77°F)

Other information

â—¾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

PRINCIPAL DISPLAY PANEL

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-764
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSE, UNSPECIFIED 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 
Product Characteristics
Colorwhite (white to off white) Score2 pieces
ShapeRECTANGLE (rounded off rectangualr) Size9mm
FlavorImprint CodeG;4
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-764-5414 TABLET, COATED in 1 BOTTLE
2NDC:62207-764-491000 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20927405/28/2018
Labeler - Granules India Ltd (915000087)
Establishment
NameAddressID/FEIOperations
Granules India Ltd918609236manufacture(62207-764)

 
Granules India Ltd

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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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