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Famotidine

Ipca Laboratories Limited
Ipca Laboratories Limited

Famotidine Tablets USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts:

Active ingredient ( in each tablet)

For 10 mg:

Famotidine USP, 10 mg

For 20 mg :

Famotidine USP, 20 mg

Purpose

Acid reducer

Famotidine 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

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

  • 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

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

Famotidine

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

Famotidine

Famotidine

Famotidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57451-5065
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
STARCH, PREGELATINIZED CORN
COLLOIDAL SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSES
hydroxypropyl cellulose
titanium dioxide
polyethylene glycol
talc
ferric oxide red

Product Characteristics

Color Size Imprint Code Shape
PINK 8 mm 035 ROUND

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 2010-06-25


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Be sure to consult your doctor before taking any medication!
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