Label: SOHMED ACID REDUCER- aluminum hydroxide and magnesium carbonate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 50405-002-50 - Packager: SOHM 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 August 19, 2013
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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- Warnings
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- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
SOHMED ACID REDUCER
aluminum hydroxide and magnesium carbonate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50405-002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 160 mg MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 105 mg Inactive Ingredients Ingredient Name Strength ALGINIC ACID (UNII: 8C3Z4148WZ) CALCIUM STEARATE (UNII: 776XM7047L) MANNITOL (UNII: 3OWL53L36A) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STARCH, CORN (UNII: O8232NY3SJ) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) FD&C YELLOW No. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) LACTOSE (UNII: J2B2A4N98G) DEXTROSE (UNII: IY9XDZ35W2) TALC (UNII: 7SEV7J4R1U) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color YELLOW Score no score Shape ROUND Size 18mm Flavor TROPICAL FRUIT PUNCH Imprint Code CRX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50405-002-50 1 in 1 CARTON 1 50 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 08/25/2013 Labeler - SOHM Inc. (009303848)