FDA Label for Famotidine

Other

Drug Facts:

Other information

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

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

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

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 - famotidinebulk figure 01

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