Label: MAG-AL PLUS- magnesium hydroxide, aluminum hydroxide and dimethicone liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/11

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

  • Active ingredient

    Delivers 30 mL

    Each 5 mL (teaspoonful) contains 200 mg Aluminum Hydroxide (equiv. to dried gel, USP), 200 mg Magnesium Hydroxide and 20 mg simethicone and provides approximately 9 mEq of acid-neutralizing capacity (ANC).

    Each 30 mL Contains:

    Magnesium Hydroxide 1200 mg

    Aluminum Hydroxide 1200 mg

    Simethicone 120 mg

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  • Purpose

    Antacid/Anti-Gas

    Sugar Free

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  • Keep Out of Reach of Children

    This package is intended for institutional use only. Keep this and all drugs out of the reach of children.

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  • Uses

    Indications: As an antacid for symptomatic relief of hyperacidity associated with the diagnosis of peptic ulcer, gastritis, peptic esophagitis, gastric hyperacidity, or hiatal hernia. As an antiflatulent to alleviate the symptoms of gas, including postoperative gas pain.

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  • Warnings

    The maximum recommended daily dosage of this product is 80 ml (16 teaspoonfuls). Do not take more than this dosage in a 24-hour period or use this dosage for more than 2 weeks except under the advice and supervision of a physician. Do not use this product except under the advice and supervision of a physician if you have kidney disease. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    Prolonged use of aluminum-containing antacids in patients with renal failure may result in or worsen dialysis osteomalacia. Elevated tissue aluminum levels contribute to the development of the dialysis encephalopathy and osteomalacia syndromes. Small amounts of aluminum are absorbed from the gastrointestinal tract and renal excretion of aluminum is impaired in renal failure. Aluminum is not well removed by dialysis because it is bound to albumin and transferrin, which do not cross dialysis membranes. As a result, aluminum is deposited in bone, and dialysis osteomalacia may develop when large amounts of aluminum are ingested orally by patients with impaired renal function.

    Aluminum forms insoluble complexes with phosphate in the gastrointestinal tract, thus decreasing phosphate absorption. Prolonged use of aluminum-containing antacids by normophosphatemic patients may result in hypophosphatemia if phosphate intake is not adequate. In its more severe forms, hypophosphatemia can lead to anorexia, malaise, muscle weakness, and osteomalacia.

    Drug Interaction Precaution:

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

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  • Directions

    Shake well before using. Adults and children 12 years and older: 10 ml to 20 ml (2 to 4 teaspoonfuls) four times a day or as directed by a physician. Children under 12 years: consult a physician.

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  • Inactive ingredients

    Sugar Free

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

    Sodium content: 4 mg/5 ml

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  • Storage

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

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  • Other

    How Supplied: White colored, peppermint flavored liquid supplied in the following oral dosage form: NDC 0121-1761-30 (unit dose cups of 30 mL, 10 x 10's).

    Pharmaceutical Associates, Inc.

    Subsidiary of Beach Products, Inc.

    201 Delaware Street

    Greenville, SC 29605

    (800) 845-8210

    www.paipharma.com

    *Compare to the active ingredients in Maalox®

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

    R12/03

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  • Principal Display Panel

    Mag-Al Plus

    5 Unit Dose Cups

    bag label
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  • INGREDIENTS AND APPEARANCE
    MAG-AL PLUS 
    magnesium hydroxide, aluminum hydroxide, simethicone liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55154-9429(NDC:0121-1761)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE) MAGNESIUM HYDROXIDE 1200 mg  in 30 mL
    ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 1200 mg  in 30 mL
    DIMETHICONE (DIMETHICONE) DIMETHICONE 120 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    BUTYLPARABEN  
    HYPROMELLOSES  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SACCHARIN SODIUM  
    SORBITOL  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-9429-5 5 in 1 BAG
    1 30 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/07/2011
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK
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