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 60505-2880-0, 60505-2880-7
Set ID c816755c-055e-8cbc-9c7a-d794cda2d74b
Category HUMAN OTC DRUG LABEL
Packager Apotex Corp.
Generic Name
Product Class
Product Number
Application Number ANDA200172
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  • Active ingredient (in each tablet)

    Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 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
    • If you have kidney disease, except under the advice and supervision of a doctor

    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)
    • children under 12 years; ask a doctor

  • Other information

    • do not use if printed foil 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, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide and vanillin

  • Questions?

    Call 1-800-706-5575

  • Principal Display Panel

    Maximum Strength

    Ranitidine Tablets USP, 150 mg

    Acid Reducer

    Prevents & Relieves Heartburn

    Associated with Acid Indigestion & Sour Stomach

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

    ranitidine-150mg-otc-CTN

  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-2880
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ranitidine Hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (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
    ShapeROUNDSize9mm
    FlavorImprint Code APO;RAN;150
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60505-2880-710000 in 1 BOTTLE; Type 0: Not a Combination Product07/15/201309/30/2021
    2NDC:60505-2880-03 in 1 CARTON07/15/201307/15/2014
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20017207/15/201309/30/2021
    Labeler - Apotex Corp. (845263701)
    Registrant - Apotex Inc. (209429182)
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