- SPL UNCLASSIFIED SECTION
- Active ingredient ( in each tablet)
- Purpose
- Uses
- WARNINGS
-
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
- If pregnant or breast-feeding.
- Keep out of reach of children
-
Directions
- 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
- 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
- SPL UNCLASSIFIED SECTION
-
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?
-
SPL UNCLASSIFIED SECTION
- 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 - SPL UNCLASSIFIED SECTION
-
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 tabletProduct 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 tabletProduct 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