Label: OHTAS ISAN ANTACID - calcium carbonate and sodium bicarbonate powder 

  • NDC Code(s): 49631-178-11, 49631-178-12
  • Packager: OHTA'S ISAN CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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  • Active Ingredients (in each spoonful)

    Precipitated calcium carbonate         497 mg 
    Sodium bicarbonate                         600 mg

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  • Purpose

    Precipitated calcium carbonate ............. Antacid
    Sodium bicarbonate ............................. Antacid

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  • Uses

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

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  • Warnings

    Do not use more than 3 spoonfuls 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.

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  • 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.

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.
  • Direction

    take 1 spoonful (using the spoon included with this can) with water, 3 times daily.

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  • Other Information

    each spoonful contains: sodium 164 mg.

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  • Inactive ingredients

    cinnamon bark, citrus unshiu peel, clove, fennel, gentian, menthol, nutmeg, powdered picrasma wood.

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  • PRINCIPAL DISPLAY PANEL

    Ohta's Isan

    NDC 49631-178-11

    DO NOT USE IF IMPRINTED SAFETY SEAL AROUND THIS CAN IS BROKEN OR MISSING.

    ANTACID POWDER

    NET WT 2.65 OZ (75g)

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

    PRODUCT OF JAPAN

    75 Gram Can
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  • INGREDIENTS AND APPEARANCE
    OHTAS ISAN ANTACID  
    calcium carbonate, sodium bicarbonate powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49631-178
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Calcium Carbonate (Carbonate Ion) Calcium Carbonate 1 g  in 1 g
    Sodium Bicarbonate (Bicarbonate Ion) Sodium Bicarbonate 1 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Cinnamon  
    Tangerine  
    Clove  
    Fennel  
    Gentiana Lutea Root  
    Menthol  
    Nutmeg  
    Picrasma Quassioides Wood  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49631-178-11 75 g in 1 CAN
    2 NDC:49631-178-12 140 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 10/16/2000
    Labeler - OHTA'S ISAN CO., LTD (690771738)
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