MAG-AL PLUS XS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]

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MAG-AL PLUS XS (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]
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NDC 0121-1762-30
Set ID db0c47ab-5296-4195-9fa6-2e338b665094
Category HUMAN OTC DRUG LABEL
Packager Pharmaceutical Associates, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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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) 400 mgAntacid
    Magnesium hydroxide 400 mgAntacid
    Simethicone 40 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 8 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 8 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 two times a day or as directed by a physician
    children under 12 yearsconsult a physician
  • Other information

    • each 5 mL contains: magnesium 167 mg, sodium 2.24 mg
    • store at controlled room temperature 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
    • protect from freezing
    • White colored, cherry flavored liquid supplied in the following oral dosage form:

    NDC 0121-1762-30: 30 mL unit dose cup. Case contains 100 unit dose cups of 30 mL packaged in 10 trays of 10 unit dose cups each.

    *Maalox is a registered trademark of Novartis Consumer Health, Inc.

  • 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
    www.paipharma.com

  • PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label

    * Compare to the
    active ingredients
    in Maalox ® Max™

    NDC 0121-1762-30

    MAG-AL PLUS XS
    Maximum Strength Antacid/ Anti-Gas
    Sugar Free

    Each 30 mL contains:

    Magnesium Hydroxide 2400 mg
    Aluminum Hydroxide 2400 mg
    Simethicone 240 mg

    SHAKE WELL

    USUAL DOSAGE: See attached Drug Facts

    This unit-dose package is not child-resistant.

    Store at 20° - 25°C (68° - 77°F)
    [See USP Controlled Room Temperature].
    Protect from freezing.

    10 x 30 mL Unit-Dose Cups

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    T1762300519
    R05/19

    PRINCIPAL DISPLAY PANEL - 30 mL Cup Tray Label
  • INGREDIENTS AND APPEARANCE
    MAG-AL PLUS  XS
    aluminum hydroxide, magnesium hydroxide, and dimethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1762
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE400 mg  in 5 mL
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg  in 5 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE40 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)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1762-3010 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(0121-1762)
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