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

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OHTAS ISAN ANTACID (MAGNESIUM ALUMINOSILICATE, CALCIUM CARBONATE, SODIUM BICARBONATE) TABLET [OHTA'S ISAN CO., LTD]
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NDC 49631-182-11
Set ID 6fe3f999-0c6c-bf3f-a0c5-d84705bbc94e
Category HUMAN OTC DRUG LABEL
Packager OHTA'S ISAN CO., LTD
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active Ingredients (in each tablet)

    Magnesium aluminometasilicate        125mg 
    Precipitated calcium carbonate         200mg 
    Sodium bicarbonate                         200mg

  • 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 6 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 physician.

  • 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

    chew 2 tablets, 3 times daily.

  • Other Information

    each tablet contains: sodium 55 mg.

  • 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 49631-182-11

    Ohta's Isan

    ANTACID TABLETS
    Herb Flavored Antacid for the relief of heartburn, sour stomach, acid indigestion and upset stomach associated with these symptoms.

    40 CHEWABLE TABLETS IN FOIL PACKET

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

    DO NOT USE IF A CARTON IS DAMAGED OR FOIL PACK EACH TABLET SEALED IN IS BROKEN


    PRODUCT OF JAPAN

    40 Tablets
  • INGREDIENTS AND APPEARANCE
    OHTAS ISAN ANTACID  
    magnesium aluminosilicate, calcium carbonate, sodium bicarbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49631-182
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Almasilate (UNII: OZQ8O62H53) (Almasilate - UNII:OZQ8O62H53) Almasilate125 mg
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate200 mg
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate200 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
    ColorBROWN (Sand Color) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code OHTA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49631-182-111 in 1 CARTON
    140 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/16/2000
    Labeler - OHTA'S ISAN CO., LTD (690771738)
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