Label: MI-ACID REGULAR STRENGTH- aluminum hydroxide, magnesium hydroxide, dimethicone suspension

  • 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 July 15, 2013

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

View All Sections
  • Active ingredients (in each 5 mL teaspoonful)

    Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

    Magnesium hydroxide 200 mg

    Simethicone 20mg

  • Purposes

    Antacid

    Antigas

  • Uses

    relieves

    • heartburn
    • sour stomach
    • acid indigestion
    • the symptoms referred to as gas
  • Warnings

    Ask a doctor before use if you have

    • kidney disease

    • a magnesium-restricted diet

    taking a prescription drug. Ask a doctor or pharmacist before use if you are

    Antacids may interact with certain prescription drugs.

    symptoms last more than 2 weeks Stop use and ask a doctor if

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

    Keep out of reach of children.

  • Directions

    • shake well before use

    • adults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor

    • do not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks

    • children under 12 years: ask a doctor

  • Other information

    • magnesium 85 mg, sodium 1 mg each 5 mL teaspoonful contains:

    • store at room temperature

    • protect from freezing

     • keep tightly closed

    • TAMPER-EVIDENT: Do not use if breakaway band on bottle is missing or broken.

  • Inactive ingredients

    benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

  • PRINCIPAL DISPLAY PANEL

    Label Image
  • INGREDIENTS AND APPEARANCE
    MI-ACID REGULAR STRENGTH  
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-0004(NDC:0904-0004)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE200 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE200 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64725-0004-112 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/2011
    Labeler - TYA Pharmaceuticals (938389038)
    Registrant - TYA Pharmaceuticals (938389038)
    Establishment
    NameAddressID/FEIBusiness Operations
    TYA Pharmaceuticals938389038RELABEL(64725-0004) , REPACK(64725-0004)
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!