Label: PREMIER VALUE FAMOTIDINE- famotidine tablet, film coated

  • NDC Code(s): 68016-008-01, 68016-010-81, 68016-010-82
  • Packager: Premier Value
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 27, 2019

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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

    • 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 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

    • store at 20° to 25° C (68° to 77° F)
    • 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

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue,
    Wayne, PA 19087

  • PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

    †COMPARE TO THE ACTIVE INGREDIENT
    IN MAXIMUM STRENGTH PEPCID AC®

    Premier
    Value ®

    MAXIMUM STRENGTH
    Famotidine Tablets, USP 20 mg
    Acid Controller

    Acid Reducer

    ✓
    Just One Tablet
    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    25 Tablets

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label

    Premier
    Value ®

    MAXIMUM STRENGTH
    Famotidine Tablets, USP 20 mg
    Acid
    Controller

    Acid Reducer

    ✓
    Just One Tablet
    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    25 Tablets

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    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
    ColorpinkScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 035
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-010-8130 in 1 BLISTER PACK; Type 0: Not a Combination Product06/25/2010
    2NDC:68016-010-8260 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028306/25/2010
    PREMIER VALUE FAMOTIDINE 
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-008
    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:68016-008-0125 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09028307/23/2010
    Labeler - Premier Value (101668460)
    Registrant - Sun Pharmaceutical Industries Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(68016-010, 68016-008)
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