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Famotidine by Dr.Reddys Laboratories Limited

Medically reviewed on Nov 22, 2017

Dosage form: tablet
Ingredients: FAMOTIDINE 10mg
Labeler: Dr.Reddys Laboratories Limited
NDC Code: 55111-118

Dr.Reddy's Laboratories Limited

Active ingredient (in each tablet)

Famotidine USP, 10 mg/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
  • 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 (for Famotidine 20 mg)
  • with other acid reducers

Ask a doctor before use if you have
  • 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
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

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.

Directions
  • For Famotidine 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 at any time from 15 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
  • For Famotidine 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
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F) [See USP controlled Room Temperature]
  • protect from moisture and light

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, synthetic red iron oxide (only in 10 mg), talc and titanium dioxide

Questions or comments?

Call 1-888-375-3784

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 vegetables
  • Eat slowly and avoid big meals
  • If overweight, lose weight
  • Quit smoking

Famotidine 10 mg

Container Label

Container Carton Label

Famotidine 20 mg

Container Label

Container Carton Label

FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-118
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
HYPROMELLOSES 
STARCH, CORN 
POLYETHYLENE GLYCOL 
TALC 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeC;118
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-118-301 BOTTLE (BOTTLE) in 1 CARTON
130 TABLET (TABLET) in 1 BOTTLE
2NDC:55111-118-601 BOTTLE (BOTTLE) in 1 CARTON
260 TABLET (TABLET) in 1 BOTTLE
3NDC:55111-118-901 BOTTLE (BOTTLE) in 1 CARTON
390 TABLET (TABLET) in 1 BOTTLE
4NDC:55111-118-181 BOTTLE (BOTTLE) in 1 CARTON
4180 TABLET (TABLET) in 1 BOTTLE
5NDC:55111-118-244 BLISTER PACK (CARTON) in 1 CARTON
56 TABLET (TABLET) in 1 BLISTER PACK
6NDC:55111-118-353 BLISTER PACK (BLISTER PACK) in 1 CARTON
66 TABLET (TABLET) in 1 BLISTER PACK
7NDC:55111-118-813 BLISTER PACK (BLISTER PACK) in 1 CARTON
710 TABLET (TABLET) in 1 BLISTER PACK
8NDC:55111-118-791 BLISTER PACK (BLISTER PACK) in 1 CARTON
810 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736709/30/2006
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-396
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
HYPROMELLOSES 
STARCH, CORN 
POLYETHYLENE GLYCOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeL1
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-396-501 BOTTLE (BOTTLE) in 1 CARTON
150 TABLET (TABLET) in 1 BOTTLE
2NDC:55111-396-442 BOTTLE (BOTTLE) in 1 CARTON
2NDC:55111-396-01100 TABLET (TABLET) in 1 BOTTLE
3NDC:55111-396-321 BOTTLE (BOTTLE) in 1 CARTON
3170 TABLET (TABLET) in 1 BOTTLE
4NDC:55111-396-081 BLISTER PACK (BLISTER PACK) in 1 CARTON
48 TABLET (TABLET) in 1 BLISTER PACK
5NDC:55111-396-165 BLISTER PACK (BLISTER PACK) in 1 CARTON
55 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736709/30/2006
Labeler - Dr.Reddys Laboratories Limited (650562841)
Establishment
NameAddressID/FEIOperations
Dr.Reddys Laboratories Limited918608162analysis, manufacture
Establishment
NameAddressID/FEIOperations
Reed Lane Inc001819879pack
Establishment
NameAddressID/FEIOperations
Dr. Reddy's Laboratories Louisiana LLC830397282analysis

 
Dr.Reddys Laboratories Limited

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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