Label: ANTACID DOUBLE STRENGTH- aluminum hydroxide, magnesium hydroxide, simethicone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 53807-158-05, 53807-158-12 - Packager: Rij 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 April 30, 2018
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL) (One teaspoonful)
- Purpose
- Uses
- Warnings
- Directions
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Other information
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- TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.
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- Store at room temperature 15º - 30ºC (59º - 86ºF)
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- keep tightly closed
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- protect from freezing
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- each teaspoon (5 mL) contains: magnesium 165 mg
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- each teaspoon (5 mL) contains: sodium 1 mg
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- does not meet USP requirements for preservative effectiveness
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTACID DOUBLE STRENGTH
aluminum hydroxide, magnesium hydroxide, simethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-158 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 5 mL MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE 400 mg in 5 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 40 mg in 5 mL Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) BUTYLPARABEN (UNII: 3QPI1U3FV8) SACCHARIN (UNII: FST467XS7D) SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) SORBITOL (UNII: 506T60A25R) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) LEMON OIL (UNII: I9GRO824LL) Product Characteristics Color WHITE (opaque) Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-158-05 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 2 NDC:53807-158-12 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part332 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-158)
