Your browser does not support JavaScript! FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]
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RxNorm Names

FAMOTIDINE tablet, film coated
[Amerisource Bergen]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 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 to60 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

  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture
  • read the directions and warnings before use
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

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

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

PRINCIPAL DISPLAY PANEL

GOOD NEIGHBOR PHARMACY®

NDC 46122-0168-78

Compare to the active ingredient of Maximum Strength Pepcid® AC

famotidine tablets USP, 20 mg

Acid Reducer

Maximum Strength

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

100 tablets

Distributed By: AmerisourceBergen

5098331/R0812

100's bottle label

FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:46122-168
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 036
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-168-78100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028307/23/2010
Labeler - Amerisource Bergen (007914906)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(46122-168)

Revised: 10/2012
 
Amerisource Bergen

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