RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]

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RANITIDINE (RANITIDINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.]
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NDC 60505-0160-3, 60505-0160-4, 60505-2881-3, 60505-2881-7, 60505-2881-8
Set ID 66922e9e-3797-6ddb-7f43-8c56bfd8f67a
Category HUMAN OTC DRUG LABEL
Packager Apotex Corp.
Generic Name
Product Class
Product Number
Application Number ANDA075167
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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
    • 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 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)
      • do not chew tablet
    • children under 12 years: ask a doctor

  • Other information

    • do not use if seal under bottle cap is broken or torn
    • 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

    carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide

  • Questions?

    Call 1-800-706-5575

  • Principal Display Panel- Bottle Carton - 75 mg 30 Tablets

    Regular Strength

    Ranitidine Tablets USP, 75 mg

    Acid Reducer

    Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    Distributed by: Apotex Corp. Weston, Florida 33326, USA.

    ranitidine_75mg_otc_btl_ctn.jpg

  • Principal Display Panel- Blister Carton - 75 mg 30 Tablets

    Regular Strength

    Ranitidine Tablets USP, 75 mg

    Acid Reducer

    Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

    Distributed by: Apotex Corp. Weston, Florida 33326, USA.

    blis-carton-75mg-30s.jpg

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-2881
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7) Ranitidine75 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polydextrose (UNII: VH2XOU12IE)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Vanillin (UNII: CHI530446X)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapePENTAGON (5 sided)Size8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60505-2881-31 in 1 CARTON01/24/2005
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:60505-2881-81 in 1 CARTON01/24/2005
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:60505-2881-71 in 1 CARTON01/24/2005
    31000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516701/24/2005
    RANITIDINE 
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-0160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ranitidine Hydrochloride (UNII: BK76465IHM) (Ranitidine - UNII:884KT10YB7) Ranitidine75 mg
    Inactive Ingredients
    Ingredient NameStrength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Polydextrose (UNII: VH2XOU12IE)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Vanillin (UNII: CHI530446X)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScoreno score
    ShapePENTAGON (5 sided)Size8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60505-0160-31 in 1 CARTON12/22/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:60505-0160-43 in 1 CARTON12/22/2016
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07516712/22/2016
    Labeler - Apotex Corp. (845263701)
    Registrant - Apotex Inc. (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc.209429182manufacture(60505-2881, 60505-0160) , analysis(60505-2881, 60505-0160)
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