Label: MAGNESIUM OXIDE tablet
- NDC Code(s): 54738-973-12
- Packager: Richmond Pharmaceuticals, 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 27, 2019
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- ACTIVE INGREDIENT (In each tablet)
- USES
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WARNINGS
Ask a doctor or pharmacist before use if you are:
taking a prescription drug. Antacids may interact with certain prescription drugs.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAGNESIUM OXIDE
magnesium oxide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-973 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 400 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white (Off) Score no score Shape ROUND Size 12mm Flavor Imprint Code AP;136 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54738-973-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 02/01/2016 Labeler - Richmond Pharmaceuticals, Inc. (043569607) Registrant - Advance Pharmaceutical, Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical, Inc. 078301063 manufacture(54738-973)