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

  • NDC Code(s): 49631-178-21, 49631-178-22
  • Packager: OHTA'S ISAN CO., LTD
  • 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 March 24, 2016

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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, l-menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

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  • Principal Display Panel - Can Label

    Ohta's Isan NDC 49631-178-21

    ANTACID POWDER

    NET WT 2.65 OZ (75g)

    Principal Display Panel - Can Label
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  • Principal Display Panel - Can Label

    Ohta's Isan NDC 49631-178-22

    ANTACID POWDER

    NET WT 4.94 OZ (140g)

    Principal Display Panel - Can Label
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  • INGREDIENTS AND APPEARANCE
    OHTAS ISAN ANTACID  
    calcium carbonate, sodium bicarbonate powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49631-178
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Calcium Carbonate (UNII: H0G9379FGK) (Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate 1 g  in 1 g
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate 1 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Cinnamon (UNII: 5S29HWU6QB)  
    Tangerine (UNII: KH3E3096OO)  
    Clove (UNII: K48IKT5321)  
    Fennel (UNII: 557II4LLC3)  
    Gentiana Lutea Root (UNII: S72O3284MS)  
    Levomenthol (UNII: BZ1R15MTK7)  
    Nutmeg (UNII: AEE24M3MQ9)  
    Picrasma Quassioides Wood (UNII: 75EIV4LX7W)  
    Magnesium Carbonate (UNII: 0E53J927NA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49631-178-21 75 g in 1 CAN; Type 0: Not a Combination Product
    2 NDC:49631-178-22 140 g in 1 CAN; Type 0: Not a Combination Product
    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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