CETIRIZINE HYDROCHLORIDE tablet

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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

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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
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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

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 57451-5067-1	10000 in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077498	12/27/2007

Labeler - Ipca Laboratories Limited (862179827)

Registrant - Ipca Laboratories Limited (650387009)

Name	Address	ID/FEI	Business Operations
Establishment
Ipca Laboratories Limited		677600550	Manufacture

Cetirizine Hydrochloride by