Label: MI ACID- calcium carbonate, magnesium hydroxide tablet, chewable

  • 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 January 19, 2022

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  • Active ingredients (in each tablet)

    Calcium carbonate 700 mg

    Magnesium hydroxide 300 mg

  • Purpose

    Antacid

    Antacid

  • Uses

    • relieves:
    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • KEEP OUT OF REACH OF CHILDREN

    Enter section text here

  • Warnings


    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet

    Ask a doctor or pharmacist before use if

    you are

    • taking a prescription drug. Antacids may interact with certain prescription drugs.

    Do not take more than 8 tablets 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 doctor.

    Keep out of reach of children. In case of overdose get a medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    • chew 2 to 4 tablets thoroughly as needed between meals and at bedtime or as directed by a doctor.
  • Other information

    • each tablet contains: calcium 280 mg and magnesium 125 mg
    • do not use if printed seal under cap is torn or missing.
    • store at room temperature
    • keep tightly closed and dry
  • INACTIVE INGREDIENT

    corn starch, D&C yellow no. 10 lake, FD&C blue no. 1 lake, flavor, magnesium stearate, maltodextrin, sorbitol, sugar

  • PDP

    Mi-AcidTM

    Double Strength Antacid Tablets

    Calcium Rich Antacid

    Cool Mint Flavor

    70 Chewable Tablets

    Compare to the Active ingredients in Mylanta® Double StrengthLabel

  • INGREDIENTS AND APPEARANCE
    MI ACID 
    calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE700 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE300 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeROUNDSize16mm
    FlavorMINT (Cool Mint) Imprint Code GDC111
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5115-7170 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2020
    Labeler - Major Pharmaceuticals (191427277)
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