MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]

MAG-AL PLUS XS (MAGNESIUM HYDROXIDE, ALUMINUM HYDROXIDE, SIMETHICONE) SUSPENSION [CARDINAL HEALTH]
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NDC 55154-9422-5
Set ID 8ea0287c-2264-4b5d-8f37-2cf3733936c7
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART331
  • SPL UNCLASSIFIED SECTION

    Maximum Strength Antacid/Anti-Gas
    Sugar-Free

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

    *Compare to the active ingredients in Maalox®

  • DESCRIPTION

    Each 5 mL (teaspoonful) contains 400 mg aluminum hydroxide (equiv. to dried gel, USP), 400 mg magnesium hydroxide and 40 mg simethicone and provides approximately 18 mEq of acid-neutralizing capacity (ANC).

  • Inactive Ingredients

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

    Sodium content: 4 mg/5 mL

  • 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.

  • 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.

  • WARNINGS

    The maximum recommended daily dosage of this product is 60 mL (12 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.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    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.

  • HOW SUPPLIED

    White colored, cherry flavored liquid supplied in the following oral dosage form: Overbagged with 5 cups per bag, NDC 55154-9422-5

    STORAGE

    Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F) [See USP]. Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    R04/14

    Pharmaceutical
    Associates, Inc.
    Greenville, SC 29605

    Distributed by:
    Cardinal Health

    Dublin, OH 43017

  • Principal Display Panel

    Mag-Al Plus XS

    5 Cups

    bag label
  • INGREDIENTS AND APPEARANCE
    MAG-AL PLUS XS 
    magnesium hydroxide, aluminum hydroxide, simethicone suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9422(NDC:0121-1762)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2400 mg  in 30 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE240 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-9422-55 in 1 BAG06/07/2011
    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 finalpart33106/07/2011
    Labeler - Cardinal Health (603638201)

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