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 49631-178-13
Set ID 8723fe90-8402-4511-b6c6-b71cf98513e3
Category HUMAN OTC DRUG LABEL
Packager OHTA'S ISAN CO.,LTD.
Generic Name
Product Class
Product Number
Application Number PART331
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each packet )

    Precipitated calcium carbonate 497 mg

    Sodium bicarbonate 600 mg

  • Purpose

    Antacid

    Antacid

  • Uses

    relieves:

    • heartburn
    • sour stomach
    • acid indigestion
    • upset stomach due to these symptoms
  • Warnings

    Do not take more than 3 packets 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 of a pharmacist before use if you are

    • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
    • on a sodium-restricted diet.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Direction

    take 1 packet with water, 3 times daily, or as directed by a physician.

  • Other information

    each packet contains: sodium 164 mg.

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 16 Packets Box Label

    NDC 49631-178-13

    Graphic – Ohta's Isan Logo

    Ohta's Isan ANTACID POWDER

    Heartburn Herb Flavored

    Acid Upset

    Indigestion Stomach

    OHTA'S ISAN MADE IN JAPAN 16 Packets

    Principal Display Panel – 16 Packets Box 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:49631-178-131 in 1 BOX07/01/2017
    116 in 1 DOSE PACK
    11.3 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33107/01/2017
    Labeler - OHTA'S ISAN CO.,LTD. (690771738)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHTA'S ISAN CO.,LTD.715739137ANALYSIS(49631-178) , MANUFACTURE(49631-178) , PACK(49631-178) , PARTICLE SIZE REDUCTION(49631-178) , STERILIZE(49631-178)
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