Famotidine tablet, film coated

Active ingredient (in each tablet)

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

  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor
  • 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.

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

  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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

  • store at 20 to 25C (68 to 77F)
  • protect from moisture
  • read the directions and warnings before use
  • keep the carton. It contains important information.

Inactive ingredients

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

Call 1-800-406-7984

Patient information

  • JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.

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

Ingredients and appearance - Product information

Famotidine tablet, film coated- Famotidine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37808-036
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Famotidine ( UNII: 5QZO15J2Z8)( Famotidine - UNII: 5QZO15J2Z8 ) 20 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hydroxypropyl cellulose (1200000 mw) ( UNII: RFW2ET671P)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Starch, corn ( UNII: O8232NY3SJ)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color white Size 8 mm
Shape ROUND Score 1
Imprint Code 036

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090283 USA

Labeler - HEB( 007924756)

Establishment

Name ID/FEI Business Operations
HEB 007924756 manufacture( 37808-036)

Principal display panel - 20 mg tablet bottle carton

Compare to Maximum Strength Pepcid AC ®
active ingredient

NDC 37808-036-50

H-E-B ®

Maximum Strength
Acid Controller
Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet
Prevents & Relieves Heartburn
Due to Acid Indigestion

actual size

50 TABLETS