FAMOTIDINE- famotidine tablet 
Apotex Corp.

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Active Ingredient (in each tablet)
Famotidine 10 mg

Purpose
Acid reducer

Uses

  • relieves heartburn associated with acid indigestion and sour stomach

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 besigns 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

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
    You may report side effects to FDA at 1-800-FDA-1088
    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

  • adults and children 12 years and over:
    • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • 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
  • store at 20°-25°C (68°-77°F)
  • protect from moisture and light

Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, red ferric oxide, yellow ferric oxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid and titanium dioxide

WHAT YOU SHOULD KNOW ABOUT Famotidine Tablets USP, 10 mg Acid Reducer
A non-prescription stomach medicine

FAMOTIDINE TABLETS USP, 10 mg contains a medicine, different from antacids, that doctors have prescribed for years to treat acid-related problems in millions of people.

How to use FAMOTIDINE TABLETS USP, 10 mg

TO RELIEVE SYMPTOMS Swallow 1 tablet with a glass of water (do not chew)

Manufactured by:Manufactured for:
Apotex Inc.Apotex Corp.
Toronto, OntarioWeston, Florida
Canada M9L 1T933326

Revised: July 2008

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

APOTEX CORP. NDC 60505-0109-1

Famotidine Tablets USP

10 mg

1000 bottle count

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FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:60505-0109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSE 2910 (15000 MPA.S) 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScorescore with uneven pieces
ShapeSQUARESize5mm
FlavorImprint Code 10
Contains    
Packaging
#Item CodePackage Description
1NDC:60505-0109-11000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07561003/12/200202/01/2008
Labeler - Apotex Corp. (845263701)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.255092496analysis(60505-0109), manufacture(60505-0109)

Revised: 05/2013
 
Apotex Corp.