NDC | 50090-3401-0 |
Set ID | 60518af3-965f-4d00-853a-9551fc3c398c |
Category | HUMAN OTC DRUG LABEL |
Packager | A-S Medication Solutions |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART332 |
- Active ingredients (in each 10 mL)
- Purpose
- Uses
-
Warnings
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug. Antacids may interact with certain prescription drugs.
-
Directions
- •
- shake well before using
- •
- only use the dose cup provided
- •
- adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
- •
- do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
- •
- children under 12 years: consult a physician
- Other information
- Inactive ingredients
- Questions or comments?
- Aluminum hydroxide, Magnesium hydroxide, Simethicone
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INGREDIENTS AND APPEARANCE
GOOD SENSE ANTACID
aluminum hydroxide, magnesium hydroxide, simethicone suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-3401(NDC:0113-0851) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 400 mg in 10 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 10 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg in 10 mL Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) PEPPERMINT OIL (UNII: AV092KU4JH) Product Characteristics Color WHITE (opaque) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-3401-0 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 02/04/2003 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-3401)