Label: ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE- aluminum hydroxide, magnesium hydroxide, and simethicone suspension
- NDC Code(s): 57237-316-03, 57237-316-31, 57237-324-03, 57237-324-31
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 17, 2024
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- Official Label (Printer Friendly)
- PURPOSE
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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
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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) contains magnesium 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) contains magnesium 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
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QUESTIONS
NDC Information -
1,200-1,200-120 mg/30 mLEach 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 1,200 mg, Magnesium hydroxide 1,200 mg and Simethicone 120 mg and is supplied in the following oral dosage forms:
NDC 57237-316-03 unit dose cup 30 mL
NDC 57237-316-31 (100 x 30 mL) unit-dose cups
2,400-2,400-240 mg/30 mLEach 30 mL of Aluminium Hydroxide / Magensium Hydroxide / Simethicone contains Aluminum hydroxide 2,400 mg, Magnesium hydroxide 2,400 mg and Simethicone 240 mg and is supplied in the following oral dosage forms:
NDC 57237-324-03 unit dose cup 30 mL
NDC 57237-324-31 (100 x 30 mL) unit-dose cups - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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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:57237-316 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:57237-316-31 100 in 1 BOX, UNIT-DOSE 08/15/2023 1 NDC:57237-316-03 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 08/15/2023 ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE AND SIMETHICONE
aluminum hydroxide, magnesium hydroxide, and simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-324 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:57237-324-31 100 in 1 BOX, UNIT-DOSE 07/05/2023 1 NDC:57237-324-03 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 07/05/2023 Labeler - Rising Pharma Holdings, Inc. (116880195)
