Label: STOMACHIN ANTACID- magnesium carbonate and sodium bicarbonate capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 17, 2011

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  • Active ingredients (in each capsule) Purpose

    Magnesium carbonate 58mg ................... Antacid

    Sodium bicarbonate 809mg .................... Antacid


  • Uses

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach from overindulgence in food or drink
  • Stop use and as a doctor if

    • symptoms persit or worsen
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PREGNANCY OR BREAST FEEDING

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

  • INDICATIONS & USAGE

    Antacid

  • Warnings


  • Directions

    TAke two capsules with water 3 times a day

  • Do not use

    more than 6 capsules in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, expect under the advice and supervision of a physician.

  • Inactive ingredients

    clove, hydroxypropyl cellulose, licorice, menthol, rhubarb
  • Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug.  Antacid may interact with certain prescription drugs
    • on magnesium or sodium restrict diet.
  • PRINCIPAL DISPLAY PANEL

    Image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    STOMACHIN ANTACID 
    magnesium carbonate and sodium bicarbonate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43337-9328
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Magnesium carbonate (UNII: 0E53J927NA) (Magnesium cation - UNII:T6V3LHY838, Carbonate ion - UNII:7UJQ5OPE7D) Magnesium carbonate58 mg  in 1 g
    Sodium bicarbonate (UNII: 8MDF5V39QO) (Sodium cation - UNII:LYR4M0NH37, Bicarbonate ion - UNII:HN1ZRA3Q20) Sodium bicarbonate809 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Clove (UNII: K48IKT5321) 29 mg  in 1 g
    Hydroxypropyl Cellulose (UNII: RFW2ET671P)  
    Licorice (UNII: 61ZBX54883) 86 mg  in 1 g
    Menthol (UNII: L7T10EIP3A) 4 mg  in 1 g
    Rhubarb (UNII: G280W4MW6E) 14 mg  in 1 g
    Product Characteristics
    Colorwhite (Beige) Scoreno score
    ShapeCAPSULE (Capsule) Size21mm
    FlavorImprint Code NA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43337-9328-62 in 1 BOX
    120 in 1 BLISTER PACK
    11 g in 1 CAPSULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33104/30/2009
    Labeler - Chang Kuo Chou Pharmaceutical Co. Ltd. (656241486)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chang Kuo Chou Pharmaceutical Co. Ltd.656241486manufacture
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