Label: ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE suspension
- NDC Code(s): 0904-7557-62, 0904-7557-73
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 7, 2025
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- Official Label (Printer Friendly)
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Drug Facts
Active ingredients Purpose
(in each 5 mL = 1 teaspoonful)Aluminum hydroxide (equiv. to dried gel, USP) 200 mg .......................... Antacid
Magnesium hydroxide 200 mg .............................................................. Antacid
Simethicone 20 mg ............................................................................... Antigas - PURPOSE
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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.
- Directions
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Other information
- each 5 mL contains: magnesium 83 mg, sodium 1.34 mg
- store at controlled room temperature 20° - 25°C (68° - 77°F) {See USP Controlled Room Temperature].
- protect from freezing
- White colored, peppermint flavored liquid supplied in the following oral dosage form:
NDC 0904-7557-62: 30 mL unit dose cup, in a tray of ten cups.
- Questions or comments? Call 1-800-845-8210
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Unit-Dose Cup Lidding Label
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INGREDIENTS AND APPEARANCE
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONE
aluminum hydroxide, magnesium hydroxide, and simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7557 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 1200 mg in 30 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 1200 mg in 30 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 120 mg in 30 mL Inactive Ingredients Ingredient Name Strength BUTYLPARABEN (UNII: 3QPI1U3FV8) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO) 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:0904-7557-73 10 in 1 CASE 07/07/2025 1 10 in 1 TRAY 1 NDC:0904-7557-62 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 Drug M001 07/07/2025 Labeler - Major Pharmaceuticals (191427277)

