Label: APTIDINE 75- ranitidine hydrochloride tablet

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

Drug Label Information

Updated February 21, 2013

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  • ACTIVE INGREDIENT

    RANITIDINE HYDROCHLORIDE

  • PURPOSE

    Acid reducer

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    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

  • DOSAGE & ADMINISTRATION

    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






  • INACTIVE INGREDIENT


    CELLULOSE, MICROCRYSTALLINE

  • INACTIVE INGREDIENT

    STARCH, CORN

  • INACTIVE INGREDIENT


    POVIDONE K30

  • INACTIVE INGREDIENT


    METHYLPARABEN

  • INACTIVE INGREDIENT


    MAGNESIUM STEARATE
  • INACTIVE INGREDIENT

    TALC
  • INACTIVE INGREDIENT


    SODIUM STARCH GLYCOLATE TYPE A POTATO

  • INACTIVE INGREDIENT


    SILICON DIOXIDE

  • PRINCIPAL DISPLAY PANEL

    product

  • INGREDIENTS AND APPEARANCE
    APTIDINE  75
    ranitidine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 80 mg
    STARCH, CORN (UNII: O8232NY3SJ) 30 mg
    POVIDONE K30 (UNII: U725QWY32X) 10 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) 3 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 20 mg
    TALC (UNII: 7SEV7J4R1U) 30 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 40 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 1 mg
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 75MG
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-031-15120 in 1 BLISTER PACK
    2NDC:46084-031-1460 in 1 BLISTER PACK
    3NDC:46084-031-1336 in 1 BLISTER PACK
    4NDC:46084-031-1212 in 1 BLISTER PACK
    5NDC:46084-031-115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07513203/01/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-031)
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