Famotidine: Package Insert and Label Information

FAMOTIDINE- famotidine tablet
Dr.Reddys Laboratories Limited

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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.
  • 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
  • kidney disease

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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 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)
  • 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

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Container Carton Label

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Famotidine 20 mg

Container Label

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Container Carton Label

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FAMOTIDINE
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
HYPROMELLOSES
STARCH, CORN
Polyethylene Glycol, Unspecified
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code C;118
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-118-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-118-30)
2 NDC:55111-118-40 1 BOTTLE in 1 CARTON contains a BOTTLE
2 40 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-118-40)
3 NDC:55111-118-60 1 BOTTLE in 1 CARTON contains a BOTTLE
3 60 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-118-60)
4 NDC:55111-118-90 1 BOTTLE in 1 CARTON contains a BOTTLE
4 90 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-118-90)
5 NDC:55111-118-04 1 BOTTLE in 1 CARTON contains a BOTTLE
5 120 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-118-04)
6 NDC:55111-118-18 1 BOTTLE in 1 CARTON contains a BOTTLE
6 180 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-118-18)
7 NDC:55111-118-24 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-118-24)
8 NDC:55111-118-35 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
8 6 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-118-35)
9 NDC:55111-118-81 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
9 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-118-81)
10 NDC:55111-118-79 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-118-79)
11 NDC:55111-118-12 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
11 12 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-118-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077367 09/30/2006
FAMOTIDINE
famotidine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-396
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
HYPROMELLOSES
STARCH, CORN
Polyethylene Glycol, Unspecified
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-396-35 1 BOTTLE in 1 CARTON contains a BOTTLE
1 25 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-396-35)
2 NDC:55111-396-50 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-396-50)
3 NDC:55111-396-65 1 BOTTLE in 1 CARTON contains a BOTTLE
3 65 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-396-65)
4 NDC:55111-396-44 2 BOTTLE in 1 CARTON contains a BOTTLE (55111-396-01)
4 NDC:55111-396-01 100 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-396-44)
5 NDC:55111-396-13 1 BOTTLE in 1 CARTON contains a BOTTLE
5 130 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-396-13)
6 NDC:55111-396-32 1 BOTTLE in 1 CARTON contains a BOTTLE
6 170 TABLET in 1 BOTTLE This package is contained within the CARTON (55111-396-32)
7 NDC:55111-396-08 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 8 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-396-08)
8 NDC:55111-396-16 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
8 5 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-396-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077367 09/30/2006
Labeler — Dr.Reddys Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr.Reddys Laboratories Limited 918608162 analysis (55111-118), manufacture (55111-118), analysis (55111-396), manufacture (55111-396)
Establishment
Name Address ID/FEI Operations
Reed Lane Inc 001819879 pack (55111-118), pack (55111-396)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Louisiana LLC 830397282 analysis (55111-118), manufacture (55111-118), analysis (55111-396), manufacture (55111-396)

Revised: 06/2020 Dr.Reddys Laboratories Limited

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