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Cetirizine Hydrochloride by Torrent Pharmaceuticals Limited

Medically reviewed on May 8, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg
Labeler: Torrent Pharmaceuticals Limited
NDC Code: 13668-590

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 13668-590-05

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:13668-590
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 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) Size7mm
FlavorImprint Code5;29
Contains    
Packaging
#Item CodePackage Description
1NDC:13668-590-3030 TABLET in 1 BOTTLE
2NDC:13668-590-01100 TABLET in 1 BOTTLE
3NDC:13668-590-25250 TABLET in 1 BOTTLE
4NDC:13668-590-05500 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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