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Ranitidine (Dr. Reddy's Laboratories Limited)

Available Formats

Dosage Form Package Information Links
TABLET 2 BLISTER PACK in 1 CARTON (55111-131-14) > 10 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-131-60) > 60 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-131-30) > 30 TABLET in 1 BOTTLE Label Information
TABLET 3 BLISTER PACK in 1 CARTON (55111-131-81) > 10 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-131-04) > 120 TABLET in 1 BOTTLE Label Information
TABLET 1 BLISTER PACK in 1 CARTON (55111-131-79) > 10 TABLET in 1 BLISTER PACK Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-131-80) > 80 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (55111-131-37) > 160 TABLET in 1 BOTTLE Label Information

Complete Ranitidine Information

  • 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

    • 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.


  • 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

    • this product is sodium and sugar free
    • Blister: do not use if individual blister unit is open or torn
      Bottle: do not use if printed foil under bottle cap is open or torn
    • avoid excessive heat or humidity
    • store at 20°-25°C (68°-77°F)

  • Inactive ingredients

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


  • QUESTIONS

    Questions? call 1-888-375-3784

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


  • Package Label Principal Display Panel

    Ranitidine Tablets USP, 75 mg - Blister Carton Label

    BlisterCarton


  • PRINCIPAL DISPLAY PANEL

    Ranitidine Tablets USP, 75 mg - container label

    container


  • PRINCIPAL DISPLAY PANEL

    Ranitidine Tablets USP, 75 mg - Container carton label

    containercarton


  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-131
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine 75 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code P75
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55111-131-24 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:55111-131-30 1 in 1 CARTON
    2 30 in 1 BOTTLE
    3 NDC:55111-131-60 1 in 1 CARTON
    3 60 in 1 BOTTLE
    4 NDC:55111-131-80 1 in 1 CARTON
    4 80 in 1 BOTTLE
    5 NDC:55111-131-90 1 in 1 CARTON
    5 90 in 1 BOTTLE
    6 NDC:55111-131-04 1 in 1 CARTON
    6 120 in 1 BOTTLE
    7 NDC:55111-131-37 1 in 1 CARTON
    7 160 in 1 BOTTLE
    8 NDC:55111-131-79 1 in 1 CARTON
    8 10 in 1 BLISTER PACK
    9 NDC:55111-131-14 2 in 1 CARTON
    9 10 in 1 BLISTER PACK
    10 NDC:55111-131-81 3 in 1 CARTON
    10 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075294 03/01/2000
    Labeler - Dr. Reddy's Laboratories Limited (650562841)