Label: GELFOS-M- aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquid
- NDC Code(s): 73442-0003-1
- Packager: I World Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated November 8, 2019
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- ACTIVE INGREDIENT
- PURPOSE
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- INDICATIONS & USAGE
- WARNINGS
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
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INGREDIENTS AND APPEARANCE
GELFOS-M
aluminum phosphate, colloidal, magnesium hydroxide, simethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73442-0003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM PHOSPHATE (UNII: F92V3S521O) (ALUMINUM PHOSPHATE - UNII:F92V3S521O) ALUMINUM PHOSPHATE 12.38 g in 20 g MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 20 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg in 20 g Inactive Ingredients Ingredient Name Strength PECTIN (UNII: 89NA02M4RX) WATER (UNII: 059QF0KO0R) AGAR (UNII: 89T13OHQ2B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73442-0003-1 4 in 1 PACKAGE 10/08/2019 1 20 g in 1 POUCH; 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 10/08/2019 Labeler - I World Pharmaceutical Co., Ltd. (688222857) Registrant - I World Pharmaceutical Co., Ltd. (688222857) Establishment Name Address ID/FEI Business Operations I World Pharmaceutical Co., Ltd 688222857 manufacture(73442-0003)