FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC]

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FAMOTIDINE TABLET, FILM COATED, EXTENDED RELEASE [SPIRIT PHARMACEUTICALS,LLC]
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NDC 68210-0007-0
Set ID 84a9a761-7d6f-4e63-814f-e7a71e0ff11b
Category HUMAN OTC DRUG LABEL
Packager SPIRIT PHARMACEUTICALS,LLC
Generic Name
Product Class
Product Number
Application Number ANDA077146
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Famotidine USP 10mg

  • 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

    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

    • 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 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

    • store at 25°-30°C (77°-86°F).
    • read the directions and warnings before use
    • protect from moisture.
    • keep the carton and package insert. They contain important information.
  • Inactive ingredients

    hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

  • Questions or comments?

    1-800-xxx-xxxx

  • SPL UNCLASSIFIED SECTION

    Distributed By: Greenbrier International, Inc.
    Chesapeake, VA 23320

  • PRINCIPAL DISPLAY PANEL - 12 Tablet Blister Pack Carton

    ASSURED™

    Compare to the
    active ingredient
    in Pepcid® AC*

    Original Strength
    HEARTBURN
    RELIEF

    FAMOTIDINE TABLETS USP, 10 mg

    ACID REDUCER

    Just One Tablet Relieves &
    Prevents Heartburn Due to
    Acid Indigestion

    12 TABLETS (12 DOSES)

    Principal Display Panel - 12 Tablet Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    FAMOTIDINE 
    famotidine tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    TALC (UNII: 7SEV7J4R1U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code W972
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0007-02 in 1 CARTON
    16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07714608/19/2013
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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