CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet 
Ipca Laboratories Limited

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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:

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

Stop use and ask a doctor if

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

If pregnant or breat-feeding

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

10-mg
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5067
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE10 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (rectangular) Size9mm
FlavorImprint Code RI52
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57451-5067-110000 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/FEIBusiness Operations
Ipca Laboratories Limited677600550Manufacture

Revised: 3/2011
Document Id: 6f2ce1a0-e50d-4feb-9b52-e70fca156c7e
Set id: 57293f46-e0ba-4f7b-a3f2-db1a798012cd
Version: 1
Effective Time: 20110325
 
Ipca Laboratories Limited