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Cetirizine Hydrochloride by Ipca Laboratories Limited

Medically reviewed on March 26, 2018

Dosage form: tablet
Ingredients: CETIRIZINE HYDROCHLORIDE 10mg
Labeler: Ipca Laboratories Limited
NDC Code: 57451-5067

Cetirizine Hydrochloride Tablets 10 mg

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 breat-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 yearsand 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

povidone, lactose monohydrate, corn starch, magnesium stearate, hypromelloses, titanium dioxide, polyethylene glycol, talc.

Questions?

call 1-800-406-7984

Manufactured for:

Ohm Laboratories Inc.

14 Terminal Road

New Brunswick, NJ 08901

Manufactured by:    

Ipca Laboratories Limited

1, Pharma Zone, SEZ Indore,

Pithampur 454775, (M.P.), India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ohm Laboratories Inc.\Ranbaxy Group Company

NDC: 57451-5067-1

Cetirizine Hydrochloride Tablets 10 mg

1x 10000 Tablets

Each tablet contains:

Cetirizine hydrochloride 10 mg

Store between 20° to 25°C (68° to 77°F)

Code                       :  MP/DRUGS/25/1/2008

Batch No.           :

Mfg. Dt.           :

Exp. Dt.           :

Manufactured for:

Ohm Laboratories Inc.

14 Terminal Road

New Brunswick, NJ 08901

Manufactured by:

Ipca Laboratories Limited

1, Pharma Zone, SEZ, Indore

Pithampur- 454775 (M.P.), India

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5067
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE10 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 
LACTOSE MONOHYDRATE 
STARCH, CORN 
MAGNESIUM STEARATE 
HYPROMELLOSES 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL 
TALC 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (rectangular) Size9mm
FlavorImprint CodeRI52
Contains    
Packaging
#Item CodePackage Description
1NDC:57451-5067-110000 TABLET (TABLET) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07749812/27/2007
Labeler - Ipca Laboratories Limited (862179827)
Registrant - Ipca Laboratories Limited (650387009)
Establishment
NameAddressID/FEIOperations
Ipca Laboratories Limited677600550Manufacture

 
Ipca Laboratories 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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