Label: ACID REDUCER- ranitidine tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 19, 2021

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  • Active ingredient (in each tablet)

    Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 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 foods and beverages

  • Warnings

    Allergy alert: Do not use if you are allergic to ranitidine 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 healthcare 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

    • do not chew tablet
    • swallow tablet with a glass of water
    • adults and children 12 years and over:
      • to relieve symptoms, take 1 tablet
      • to prevent symptoms, take 1 tablet 30 to 60 minutes before eating food or drinking beverages that cause heartburn
      • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
    • children under 12 years; ask a doctor

  • Other information

    • store at 20°C to 25°C (68°F to 77°F)
    • avoid excessive heat or humidity
    • this product is sodium and sugar free
  • Inactive ingredients

    FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • Questions?

    Call 1-800-540-3765

  • Principal Display Panel

    pdp

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 
    ranitidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-5012(NDC:57896-715)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code P75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-5012-330 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07529410/01/2018
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-5012)
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