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

  • 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 November 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each packet <1.3g>)

    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.715739137manufacture(49631-178)
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