Label: MAGNESIUM OXIDE tablet
- NDC Code(s): 0603-0213-21
- Packager: PAR Pharmaceuticals
- 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.
Updated November 10, 2020
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- Active ingredient(s)
Do not use
Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect.
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
magnesium oxide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0213 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 253 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code 306 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0603-0213-21 100 in 1 BOTTLE; Type 0: Not a Combination Product 11/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 11/10/2020 Labeler - PAR Pharmaceuticals (092733690) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 analysis(0603-0213) , label(0603-0213) , manufacture(0603-0213) , pack(0603-0213)