Famotidine by Ipca Laboratories Limited FAMOTIDINE tablet

Famotidine by

Drug Labeling and Warnings

Famotidine by is a Otc medication manufactured, distributed, or labeled by Ipca Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

WARNINGS

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

Do not use

• For 10 mg:
• with other acid reducers
• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• For 20 mg:
• with other acid reducers
• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
• if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

• frequent chest pain
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain
• had heartburn over 3 months. This may be a sign of a more serious condition.
• heartburn with lightheadedness, sweating, or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days

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:

• adults and children 12 years and over:
• to relieve symptoms, swallow 1 tablet with a glass of water.  Do not chew.
• to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn
• do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

For 20 mg

• adults and children 12 years and over:
• to relieve symptoms, swallow 1 tablet with a glass of water.  Do not chew.
• to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
• do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor

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Other information

• Store between 20° to 25°C (68° to 77°F)
• protect from moisture
• read the directions and warnings before use

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

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• 1 tablet relieves heartburn due to acid indigestion
• Famotidine prevents heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

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

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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: 57451-5065-1

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

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

INGREDIENTS AND APPEARANCE

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57451-5065
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	035
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57451-5065-1	10000 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090283	06/25/2010

FAMOTIDINE 
famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57451-5066
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	036
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57451-5066-1	10000 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090283	07/23/2010

Labeler - Ipca Laboratories Limited (862179827)

Registrant - Ipca Laboratories Limited (650387009)

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