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CETIRIZINE HYDROCHLORIDE by Torrent Pharmaceuticals Limited

Medically reviewed on May 8, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Torrent Pharmaceuticals Limited
NDC Code: 13668-030

Cetirizine Hydrochloride Tablets

Drug Facts:

Active ingredient (in each tablet)   

Cetirizine HCl 10 mg

Purpose: Antihistamine

Uses

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

Ask a doctor or pharmacist before use if you are 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 a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

  • 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.

Directions
adults and children 6 years
  and over
  one 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 over
  ask a doctor
  children under 6 years of age
  ask a doctor
  consumers with liver or kidney
  disease
  ask a doctor

Other information

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

Inactive ingredients colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

call 1-269-544-2299 weekdays

Manufactured by :

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

PRINCIPAL DISPLAY PANEL

NDC 13668-030-05

Cetirizine HCl Tablets 10 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour Relief of

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

500 Tablets 10 mg each

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13668-030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
HYPROMELLOSE 2910 (6 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE K30 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
Product Characteristics
ColorWHITE (white to off white) Scoreno score
ShapeROUND (rounded-off,rectangular shaped, film coated tablet) Size9mm
FlavorImprint Code10;30
Contains    
Packaging
#Item CodePackage Description
1NDC:13668-030-3030 TABLET in 1 BOTTLE
2NDC:13668-030-01100 TABLET in 1 BOTTLE
3NDC:13668-030-25250 TABLET in 1 BOTTLE
4NDC:13668-030-05500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07919104/15/2010
Labeler - Torrent Pharmaceuticals Limited (916488547)

 
Torrent Pharmaceuticals Limited

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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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