Label: MAG-AL PLUS- aluminum hydroxide, magnesium hydroxide, and simethicone suspension

  • NDC Code(s): 0121-1761-30
  • Packager: Pharmaceutical Associates, 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.

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Updated December 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL = 1 teaspoonful)Purpose
    Aluminum hydroxide (equiv. to dried gel, USP) 200 mgAntacid
    Magnesium hydroxide 200 mgAntacid
    Simethicone 20 mgAntigas
  • Uses

    for the relief of:

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach due to these symptoms
    • pressure and bloating commonly referred to as gas
  • Warnings

    Do not take more than 16 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physician.

    Ask a doctor before use if you have

    • kidney disease
    • a magnesium-restricted diet

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

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

    Keep out of reach of children.

  • Directions

    • shake well before using
    • do not take more than 16 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weeks
    adults and children 12 years and oldertake 2 to 4 teaspoonfuls four times a day or as directed by a physician
    children under 12 yearsconsult a physician
  • Other information

    • each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
    • store at controlled room temperature 20° - 25°C (68° - 77°F)
    • protect from freezing
    • White colored, peppermint flavored liquid supplied in the following oral dosage form:
    NDC 0121-1761-30:30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.
  • Inactive ingredients

    Butylparaben, hydroxypropyl methylcellulose, flavoring, propylene glycol, propylparaben, purified water, sodium saccharin, and sorbitol solution.

  • Questions or comments?

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

  • PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Tray Label

    Delivers 30 mL

    NDC 0121-1761-30

    MAG-AL PLUS

    Each 30 mL contains:

    Aluminum Hydroxide  1200 mg

    Magnesium Hydroxide  1200 mg

    Simethicone  120 mg

    SHAKE WELL

    USUAL DOSAGE: See attached Drug Facts

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.
    Greenville, SC 29605

    SEE INSERT

    PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Tray Label

  • INGREDIENTS AND APPEARANCE
    MAG-AL PLUS 
    aluminum hydroxide, magnesium hydroxide, and simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1761
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1761-3010 in 1 CASE01/14/2004
    110 in 1 TRAY
    130 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/14/2004
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-1761)
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