Label: ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH suspension
- NDC Code(s): 66689-060-01, 66689-060-99
- Packager: VistaPharm, Inc.
- 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 September 14, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Purposes
- Uses
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Warnings
Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacid may interact with certain prescription drugs.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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How Supplied
Alumina, Magnesia, and Simethicone Oral Suspension is a white suspension supplied as follows:
NDC 66689-060-01: 30 mL unit-dose cup
NDC 66689-060-99: Case contains 100 unit-dose cups of 30 mL (NDC 66689-060-01), packaged in 10 trays of 10 unit-dose cups each.Distributed by:
VistaPharm Inc.
Largo, FL 33771, USAVP2184
05/20
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Principal Display Panel
REGULAR STRENGTH
Alumina, Magnesia, and
Simethicone Oral Suspension
each 30 mL contains:
Aluminum Hydroxide Gel…………1200 mg
Magnesium hydroxide…………….1200 mg
Simethicone………………………..120 mg
Alcohol 0.15%
Delivers 30 mL
Store at 20°-25°C (68°-77°F). Shake Well
Distributed by: VistaPharm
Largo, FL 33771, USA
VP2187
Rev.06/20
NDC 66689-060-01
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INGREDIENTS AND APPEARANCE
ALUMINA, MAGNESIA, AND SIMETHICONE ORAL SUSPENSION REGULAR STRENGTH
alumina, magnesia, and simethicone oral suspension regular strength suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66689-060 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) 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) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL SOLUTION (UNII: 8KW3E207O2) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color WHITE (white suspension) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66689-060-99 100 in 1 CASE 09/15/2020 1 NDC:66689-060-01 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 09/15/2020 Labeler - VistaPharm, Inc. (116743084)