Label: GELUSIL- alumina, magnesia, simethicone tablet, chewable
- NDC Code(s): 65197-300-10, 65197-300-11
- Packager: WellSpring Pharmaceutical Corporation
- 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 November 21, 2022
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- Official Label (Printer Friendly)
- Active Ingredients (in each tablet)
- Purpose
- Uses
- Warnings
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Directions
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- Adults and children 12 years of age and older: Chew 2 to 4 tablets. Repeat hourly if symptoms return, or as directed by a physician
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- Children under 12 of age: ask a doctor
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- Do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician
- Other information
- Inactive ingredients
- Questions?
- Principal display panel - Carton
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INGREDIENTS AND APPEARANCE
GELUSIL
alumina, magnesia, simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-300 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 200 mg MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 200 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 24 mg SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 1 mg Inactive Ingredients Ingredient Name Strength DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) SILICON (UNII: Z4152N8IUI) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color WHITE Score no score Shape ROUND Size 16mm Flavor PEPPERMINT Imprint Code PD;GELUSIL;034 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65197-300-10 10 in 1 CARTON 09/24/2008 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:65197-300-11 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 09/24/2008 Labeler - WellSpring Pharmaceutical Corporation (110999054)