FAMOTIDINE- famotidine tablet 
Ipca Laboratories Limited

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Famotidine Tablets USP

Drug Facts:

Active ingredient ( in each tablet)

For 10 mg:

Famotidine USP, 10 mg

For 20 mg :

Famotidine USP, 20 mg

Purpose

Acid reducer

Uses

WARNINGS

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers.

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding.

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 (1-800-222-1222).

Directions

For 10 mg:

For 20 mg

Other information

Inactive ingredients

For 10 mg: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol, talc, ferric iron oxide.

For 20 mg: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol, talc.

Questions?

Call 1-800-406-7984

Tips for Managing Heartburn
■Do not lie flat or bend over after eating
■Do not wear tight fitting clothing around the stomach
■Do not eat before bedtime
■Raise the head of your bed
■Avoid heartburn - causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetablets.
■Eat slowly and avoid big meals
■If overweight, lose weight
■Quit smoking

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: 57451-5065-1

Famotidine Tablets USP 10 mg

1x 10000 Tablets

Each tablet contains:

Famotidine USP 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

Ohm Laboratories Inc.\Ranbaxy Group Company

NDC: 57451-5066-1

Famotidine Tablets USP 20 mg

1x 10000 Tablets

Each tablet contains:

Famotidine USP 20 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

20-mg
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5065
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 035
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57451-5065-110000 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028306/25/2010
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57451-5066
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 036
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57451-5066-110000 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028307/23/2010
Labeler - Ipca Laboratories Limited (862179827)
Registrant - Ipca Laboratories Limited (650387009)
Establishment
NameAddressID/FEIBusiness Operations
Ipca Laboratories Limited677600550Manufacture

Revised: 3/2011
Document Id: 65566771-7db3-4f49-ad00-8b561eade5e4
Set id: d80b4d0c-650d-454a-b5d7-d6fee102e783
Version: 1
Effective Time: 20110321
 
Ipca Laboratories Limited