Famotidine description, usages, side effects, indications, overdosage, supplying and lots more!

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Famotidine

Dr.Reddys Laboratories Limited

Dr.Reddy's Laboratories Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Famotidine USP, 10 mg/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

  • 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

Famotidine 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

Famotidine

Container Carton Label

Famotidine

Famotidine 20 mg

Container Label

Famotidine

Container Carton Label

Famotidine

Famotidine

Famotidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-118
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
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
HYPROMELLOSES
STARCH, CORN
polyethylene glycol
talc
titanium dioxide
ferric oxide red

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm C;118 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 60 in 1 BOTTLE
3 90 in 1 BOTTLE
4 180 in 1 BOTTLE
5 6 in 1 BLISTER PACK
6 6 in 1 BLISTER PACK
7 10 in 1 BLISTER PACK
8 10 in 1 BLISTER PACK
9 NDC:55111-118-79 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077367 2006-09-30


Famotidine

Famotidine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-396
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FAMOTIDINE FAMOTIDINE 20 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
HYPROMELLOSES
STARCH, CORN
polyethylene glycol
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm L1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 50 in 1 BOTTLE
2 NDC:55111-396-01 100 in 1 BOTTLE
3 170 in 1 BOTTLE
4 8 in 1 BLISTER PACK
5 5 in 1 BLISTER PACK
6 NDC:55111-396-16 5 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077367 2006-09-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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