OHTAS ISAN ANTACID (MAGNESIUM ALUMINOSILICATE, CALCIUM CARBONATE, SODIUM BICARBONATE) TABLET [OHTA'S ISAN CO., LTD]

OHTAS ISAN ANTACID (MAGNESIUM ALUMINOSILICATE, CALCIUM CARBONATE, SODIUM BICARBONATE) TABLET [OHTA'S ISAN CO., LTD]
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NDC 49631-212-01
Set ID eea230ed-8d78-9355-81a7-d08722aed708
Category HUMAN OTC DRUG LABEL
Packager OHTA'S ISAN CO., LTD
Generic Name
Product Class
Product Number
Application Number PART331
  • 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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