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

  • NDC Code(s): 0904-0004-14
  • Packager: MAJOR Pharmaceuticals Inc.
  • 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 December 21, 2021

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

  • 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


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

    Antacids may interact with certain prescription drugs.

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

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

    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

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

    • 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

  • package Label

    NDC 0904-0004-14

    MAJOR

    FAST ACTING

    MI-ACID

    Alumina, Magnesia and Simethicone Oral Suspension USP

    Regular Strength

    antacid/antigas

    ORIGINAL

    For fast, soothing Relief of:

    HEARTBURN

    ACID INDIGESTION

    and SOUR STOMACH

    compare to the active ingredients of Regular Strength MYLANTA

    12 FL OZ (355 mL)

    Alcohol: less than 0.5%

    mi-acid reg label

  • INGREDIENTS AND APPEARANCE
    MI-ACID REGULAR STRENGTH 
    aluminum hydroxide, magnesium hydroxide, dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0904-0004-14355 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/201105/01/2022
    Labeler - MAJOR Pharmaceuticals Inc. (191427277)
    Registrant - GCP Laboratories (965480861)
    Establishment
    NameAddressID/FEIBusiness Operations
    GCP Laboratories965480861manufacture(0904-0004)