Label: ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE- aluminum hydroxide, magnesium hydroxide, and simethicone suspension
- NDC Code(s): 84415-010-01, 84415-017-01
- Packager: Everpharm LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 16, 2025
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- PURPOSE
-
ACTIVE INGREDIENT
1,200-1,200-120 mg/30 mL
Active ingredient per 30mL (1 Unit Dose)
Aluminum hydroxide 1,200mg (equivalent to dried gel USP)
Magnesium hydroxide 1,200mg
Simethicone 120mg2,400-2,400-240 mg/30 mL
Active ingredient per 30mL (1 Unit Dose)
Aluminum hydroxide 2,400mg (equivalent to dried gel USP)
Magnesium hydroxide 2,400mg
Simethicone 240mgPurpose
Antacid
Antigas
- Warnings
-
Directions • shake well before use
1,200-1,200-120 mg/30 mL
• Do not use more than 4 unit dose (120 mL) in a 24 hour period or use the maximum dose for more than 2 weeks
age dose Adults and children over 12 years of age Take 30 mL, one unit dose, between meals and at bedtime, or as directed by a doctor. Do not exceed 4 x 30 mL unit dose (120 mL) in a 24 hour period Children under 12 years of age Ask a doctor 2,400-2,400-240 mg/30 mL
• Do not use more than 2 unit dose (60 mL) in a 24 hour period or use the maximum dose for more than 2 weeks
age dose Adults and children over 12 years of age Take 30 mL, one unit dose, one to two times daily or as directed by a doctor. Do not exceed 2 x 30 mL unit dose (60 mL) in a 24 hour period Children under 12 years of age Ask a doctor -
Other information
1,200-1,200-120 mg/30 mL
• each 30 mL (unit dose) containsmagnesium 510 mg and sodium 18 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• protect from freezing
• do not use if lid is torn or broke
2,400-2,400-240 mg/30 mL
• each 30 mL (unit dose) containsmagnesium 990 mg and sodium 6 mg
• store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
• protect from freezing
• do not use if lid is torn or broken
- INACTIVE INGREDIENT
- QUESTIONS
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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:84415-017 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 white Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84415-017-01 100 in 1 BOX, UNIT-DOSE 01/16/2025 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 Drug M001 01/16/2025 ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE
aluminum hydroxide, magnesium hydroxide, and simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84415-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 240 mg in 30 mL Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) BUTYLPARABEN (UNII: 3QPI1U3FV8) BENZYL ALCOHOL (UNII: LKG8494WBH) 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 CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84415-010-01 100 in 1 BOX, UNIT-DOSE 01/16/2025 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 Drug M001.15 01/16/2025 Labeler - Everpharm LLC (119288836)
