FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]

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  • FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]

FAMOTIDINE TABLET, FILM COATED [AMERISOURCE BERGEN]
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NDC 46122-168-78
Set ID 1a43eb84-da0b-4c06-ba0d-e4a469ecaa6a
Category HUMAN OTC DRUG LABEL
Packager AMERISOURCE BERGEN
Generic Name
Product Class
Product Number
Application Number ANDA090283
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    • 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

    • 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
    • store at 20° to 25° C (68° to 77° F)
    • protect from moisture
  • Inactive ingredients

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

  • Questions?

    Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

  • SPL UNCLASSIFIED SECTION

    Distributed By: AmerisourceBergen,
    1300 Morris Drive, Chesterbrook, PA 19087

  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

    NDC 46122-168-78

    GOOD
    NEIGHBOR
    PHARMACY®

    †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

    PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-168
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-168-78100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028305/01/2013
    Labeler - AMERISOURCE BERGEN (007914906)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(46122-168)
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