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Cetirizine Hydrochloride by Torrent Pharmaceuticals Limited

Medically reviewed on July 31, 2017

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Torrent Pharmaceuticals Limited
NDC Code: 13668-029

Cetirizine Hydrochloride Tablets

Drug Facts:

Active ingredient (in each tablet)

Cetirizine HCl 5 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
  1 to 2 tablets once daily depending upon
   severity of symptoms; do not take more than
   2 tablets in 24 hours.
  adults 65 years and over
  1 tablet once a day; do not take more than
  1 tablet in 24 hours
  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 13668-029-05

Cetirizine HCl Tablets 5 mg

Antihistamine

Allergy

Indoor & Outdoor Allergies

24 Hour Relief of

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

500 Tablets 5 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:13668-029
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
STARCH, CORN 
HYPROMELLOSE 2910 (6 CPS) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 400 
POVIDONE K30 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (rounded-off,rectangular shaped,film coated tablet) Size7mm
FlavorImprint Code5;29
Contains    
Packaging
#Item CodePackage Description
1NDC:13668-029-3030 TABLET (30 TABLET) in 1 BOTTLE
2NDC:13668-029-01100 TABLET (100 TABLET) in 1 BOTTLE
3NDC:13668-029-25250 TABLET (250 TABLET) in 1 BOTTLE
4NDC:13668-029-05500 TABLET (500 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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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