- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- Inactive Ingredients
- INDICATIONS
- DIRECTIONS
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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.
- HOW SUPPLIED
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INGREDIENTS AND APPEARANCE
MAG-AL PLUS XS
magnesium hydroxide, aluminum hydroxide, simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-9422(NDC:0121-1762) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 2400 mg in 30 mL ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 2400 mg in 30 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 240 mg in 30 mL Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-9422-5 5 in 1 BAG 06/07/2011 1 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 06/07/2011 Labeler - Cardinal Health (603638201)