Label: MAG-AL LIQUID- aluminum hydroxide and magnesium hydroxide suspension
- NDC Code(s): 0121-1760-30
- Packager: PAI Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 2, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
- does not meet USP requirements for preservative effectiveness
- store at controlled room temperature 20° - 25°C (68° - 77°F)
- protect from freezing
- White colored, peppermint flavored liquid supplied in the following oral dosage form:
NDC 0121-1760-30: 30 mL unit dose cup, in a tray of ten cups. - Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Dose Cup Tray Label
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INGREDIENTS AND APPEARANCE
MAG-AL LIQUID
aluminum hydroxide and magnesium hydroxide suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1760 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 200 mg in 5 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 200 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-1760-30 10 in 1 CASE 01/14/2004 1 10 in 1 TRAY 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 01/14/2004 Labeler - PAI Holdings, LLC (044940096) Establishment Name Address ID/FEI Business Operations PAI Holdings, LLC dba Pharmaceutical Associates, Inc. 097630693 manufacture(0121-1760)