Label: ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH- aluminum hydroxide, magnesium hydroxide, and simethicone suspension
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION- aluminum hydroxide, magnesium hydroxide, and simethicone suspension
- NDC Code(s): 0904-7325-62, 0904-7325-73, 0904-7326-62, 0904-7326-73
- Packager: MAJOR® PHARMACEUTICALS
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 17, 2025
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- PURPOSE
-
ACTIVE INGREDIENT
1,200-1,200-120 mg/30 mL
Active ingredients (in each 30 mL) Purpose
Aluminum hydroxide 1,200 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 1,200 mg......................................................Antacid
Simethicone 120 mg......................................................................Antigas2,400-2,400-240 mg/30 mL
Active ingredient (in each 30 mL) Purpose
Aluminum hydroxide 2,400 mg (equivalent to dried gel, USP)..............Antacid
Magnesium hydroxide 2,400 mg......................................................Antacid
Simethicone 240 mg......................................................................Antigas - Warnings
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Directions • shake well before use
1,200-1,200-120 mg/30 mL
age dose Adults and children 12 years and older 30mL, not more than 120 mL in 24 hrs Children under 6 years of age Do not use unless directed by a doctor 2,400-2,400-240 mg/30 mL
age dose Adults and children 12 years and older 30mL, not more than 60 mL in 24 hrs Children under 6 years of age Do not use unless directed by a doctor -
Other information
1,200-1,200-120 mg/30 mL
- each 30 mL containsmagnesium 510 mg and sodium 18 mg
- protect from freezing
- store at 20° to 25°C (68° to 77°F).
- do not use if lid seal is open or damaged
- retain this insert for full product information
2,400-2,400-240 mg/30 mL
- each 30 mL containsmagnesium 990 mg, sodium 30 mg
- store at 20° to 25°C (68° to 77°F).
- protect from freezing
- do not use if lid seal is open or damaged
- retain this insert for full product information
- INACTIVE INGREDIENT
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION MAXIMUM STRENGTH
aluminum hydroxide, magnesium hydroxide, and simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7326 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 240 mg in 30 mL ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 2400 mg in 30 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 2400 mg in 30 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7326-73 10 in 1 CASE 08/01/2023 1 10 in 1 TRAY 1 NDC:0904-7326-62 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 08/01/2023 ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE SUSPENSION
aluminum hydroxide, magnesium hydroxide, and simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7325 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 BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7325-73 10 in 1 CASE 08/01/2023 1 10 in 1 TRAY 1 NDC:0904-7325-62 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 07/05/2023 Labeler - MAJOR® PHARMACEUTICALS (191427277)
