Label: ACID REDUCER 150- ranitidine hydrochloride tablets 150mg tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 30, 2019

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  • Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 mg)

  • Purpose

    Acid reducer

  • Use(s)

    • relieves heartburn associated with acid indigestion and sour stomach
    • prevents heartburn associated with acid indigestion and sour stomach brought on by 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
    • if you have kidney disease, except under the advice and supervision of a 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 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
      • to prevent symptoms, swallow 1 tablet with a glass of water 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

    • do not use if printed foil under bottle cap is open or torn
    • store at 20°-25°C (68°-77°F)
    • avoid excessive heat or humidity
    • protect from light
    • this product is sugar free
  • Inactive ingredients

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

  • Questions

    call 1-888-375-3784

    SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.

    IMPORTANT: Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

  • container label

    carton

  • CARTON LABELING - PRINCIPAL DISPLAY PANEL

    bottle

  • INGREDIENTS AND APPEARANCE
    ACID REDUCER 150 
    ranitidine hydrochloride tablets 150mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-404(NDC:55111-404)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code R150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-404-341 in 1 CARTON05/14/201209/30/2019
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:21130-404-501 in 1 CARTON05/14/201209/30/2019
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:21130-404-021 in 1 CARTON05/14/201209/30/2019
    3200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07819205/14/2012
    Labeler - Safeway Inc (009137209)
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