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 November 7, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!