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

  • NDC Code(s): 0121-1761-30
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 12, 2024

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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 DrugM00101/14/2004
    Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693manufacture(0121-1761)
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