Label: RANITIDINE tablet

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

Drug Label Information

Updated May 17, 2019

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  • ACTIVE INGREDIENT(S)

    Ranitidine 150 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 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
    ◾  if you have kidney disease, except under the advice and supervision of a doctor

  • ASK A DOCTOR BEFORE USE IF

    ◾ 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 DOCTOR IF

    ◾ your heartburn continues or worsens
    ◾ you need to take this product for more than 14 days

  • PREGNANCY/BREASTFEEDING

    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)
       ◾ do not chew tablet (for cool mint tablets only)
    ◾ children under 12 years: ask a doctor



  • OTHER INFORMATION

    · safety sealed: do not use if carton is opened or if printed foil inner seal on bottle is torn or missing

    · store between 20°and 25°C (68°and 77°F)

    · protect from excessive moisture and light

  • INACTIVE INGREDIENTS

    For 150 mg:croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide

    For 150 mg cool mint:acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum,
    titanium dioxide

  • Questions or comments?

    Contact 1-855-361-3993

  • CONSUMER INFORMATION

    ranitidineimage.jpg

  • PRINCIPAL DISPLAY PANEL

    150mg

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-721
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 150;G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-721-1550 in 1 BOX05/17/2019
    1NDC:50268-721-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21024305/17/2019
    Labeler - AvPAK (832926666)
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