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

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OHTAS ISAN ANTACID (CALCIUM CARBONATE, SODIUM BICARBONATE) POWDER [OHTA'S ISAN CO., LTD]
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NDC 49631-178-21, 49631-178-22
Set ID 53380470-5748-6fa7-548e-7484ef204c0f
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 spoonful)

    Precipitated calcium carbonate         497 mg 
    Sodium bicarbonate                         600 mg

  • Purpose

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

  • Uses

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

  • 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.

  • 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

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

  • Other Information

    each spoonful contains: sodium 164 mg.

  • Inactive ingredients

    cinnamon bark, citrus unshiu peel, clove, fennel, gentian, l-menthol, nutmeg, powdered picrasma wood, magnesium carbonate.

  • 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
  • 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
  • INGREDIENTS AND APPEARANCE
    OHTAS ISAN ANTACID 
    calcium carbonate, sodium bicarbonate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49631-178
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Carbonate (UNII: H0G9379FGK) (Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate1 g  in 1 g
    Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49631-178-211 in 1 BOX10/16/2000
    175 g in 1 CAN; Type 0: Not a Combination Product
    2NDC:49631-178-221 in 1 BOX10/16/2000
    2140 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/16/2000
    Labeler - OHTA'S ISAN CO.,LTD. (690771738)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHTA'S ISAN CO.,LTD.715739137MANUFACTURE(49631-178)
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