Label: OHTAS ISAN ANTACID- magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 7, 2012

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  • Active Ingredients (in each tablet)

    Magnesium aluminometasilicate        83.3 mg 
    Precipitated calcium carbonate         133.3 mg 
    Sodium bicarbonate                         133.3 mg

  • Purpose

    Magnesium aluminometasilicate ............ Antacid 
    Precipitated calcium carbonate ............. Antacid
    Sodium bicarbonate ............................. Antacid

  • Uses

    relieves: ■ heartburn ■ acid indigestion ■ sour stomach ■ upset stomach due to these symptoms

  • Warnings

    Do not use more than 9 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

  • Ask a doctor or pharmacist before use if you are

    ■ presently taking a prescription drug. Antacids may interact with certain prescription drugs
    ■ on a sodium-restricted diet

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

  • Direction

    swallow 3 tablets with a glass of water after meals, 3 times daily

  • Other Information

    ■ each tablet contains: sodium 36.7 mg. ■ keep the carton. It contains important information.
    ■ store at 20°-25°C (68°-77°F) ■ protect from moisture

  • Inactive ingredients

    cinnamon bark, cinnamon oil, citrus unshiu peel, clove, fennel, fennel oil, gentian, lemon oil, menthol, magnesium stearate, microcrystalline cellulose, nutmeg, powdered picrasma wood.

  • PRINCIPAL DISPLAY PANEL

    NDC 49631-212-01

    Ohta's Isan ANTACID TABLETS
    Heartburn   Acid Indigestion   Upset Stomach

    45 TABLETS

    Manufactured by
    OHTA'S ISAN CO., LTD.
    3-2, SENGOKU 2-CHOME, BUNKYO-KU,
    TOKYO 112-0011, JAPAN

    PRODUCT OF JAPAN

    DO NOT USE IF A CARTON IS DAMAGED OR FOIL SEAL IS BROKEN.

    Lot. No.

    Exp. Date

    45 Tablets Label
  • INGREDIENTS AND APPEARANCE
    OHTAS ISAN ANTACID  
    magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49631-212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Almasilate (UNII: OZQ8O62H53) (Almasilate - UNII:OZQ8O62H53) Almasilate83.3 mg
    Calcium Carbonate (UNII: H0G9379FGK) (Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate133.3 mg
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate133.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    Cinnamon (UNII: 5S29HWU6QB)  
    Cinnamon Oil (UNII: E5GY4I6YCZ)  
    Tangerine (UNII: KH3E3096OO)  
    Clove (UNII: K48IKT5321)  
    Clove Oil (UNII: 578389D6D0)  
    Fennel (UNII: 557II4LLC3)  
    Fennel Oil (UNII: 59AAO5F6HT)  
    Gentiana Lutea Root (UNII: S72O3284MS)  
    Lemon Oil (UNII: I9GRO824LL)  
    Menthol (UNII: L7T10EIP3A)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Nutmeg (UNII: AEE24M3MQ9)  
    Picrasma Quassioides Wood (UNII: 75EIV4LX7W)  
    Product Characteristics
    ColorYELLOW (Pale Yellow) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49631-212-011 in 1 CARTON
    145 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/01/2012
    Labeler - OHTA'S ISAN CO., LTD (690771738)
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