Label: RANITIDINE COOL MINT- ranitidine tablet
RANITIDINE tablet

  • NDC Code(s): 62207-773-32, 62207-773-36, 62207-773-41, 62207-773-47, view more
    62207-773-58, 62207-774-36, 62207-774-41, 62207-774-47, 62207-774-58
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2024

If you are a consumer or patient please visit this version.

  • 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

  • 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

    ◾ kidney disease

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

  • 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

    ◾ do not use if individual blister unit is open or torn.

    ◾ do not use if printed foil under bottle cap is open or torn

    ◾ store at 20 0-25 0​C (68 0​-77 0​F)

    ◾ avoid excessive heat or humidity

    ◾ this product is sodium and sugar free

  • 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 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM EST.

    This product is not manufactured or distributed by Boehringer Ingelheim ® consumer health care products, distributor of Zantac 150mg and 150mg Cool Mint

  • Read the directions and warnings before use.

    Keep the carton. It contains important information including tips for managing heartburn.

    Tips for managing heartburn

    •Do not lie flat or bend over soon after eating


    •Do not eat late at night, or just before bedtime


    •Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty andfried foods, chocolate, caffeine, alcohol, even some fruits and vegetables.


    •Eat slowly and do not eat big meals


    •if you are overweight, lose weight


    •if you smoke, quit smoking


    •Raise the head of your bed


    •Wear loose fitting clothing around your stomach

  • PRINCIPAL DISPLAY PANEL

    62207-774-58-carton.jpg62207-774-47-carton.jpg62207-774-41-carton.jpg62207-773-58-carton.jpg62207-773-47-carton.jpg62207-773-41-carton.jpgranitidine-label4-jpgranitidine-label3-jpgranitidine-150mg-label2-jpgranitidine-150mg-label1-jpg62207-774-32.jpg62207-773-32.jpg62207-774-336.jpg62207-773-36-carton.jpg

  • INGREDIENTS AND APPEARANCE
    RANITIDINE  COOL MINT
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-774
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorMINTImprint Code 150;G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-774-582 in 1 CARTON06/26/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:62207-774-411 in 1 CARTON06/26/2019
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:62207-774-471 in 1 CARTON06/26/2019
    3500 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:62207-774-365 in 1 CARTON06/26/2019
    410000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21024306/26/2019
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-773
    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:62207-773-582 in 1 CARTON06/26/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:62207-773-411 in 1 CARTON06/26/2019
    224 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:62207-773-471 in 1 CARTON06/26/2019
    3500 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:62207-773-365 in 1 CARTON06/26/2019
    4NDC:62207-773-3210000 in 1 BAG; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21024306/26/2019
    Labeler - Granules India Ltd (915000087)