Label: MAGNESIUM OXIDE tablet
- 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 February 8, 2019
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SPL UNCLASSIFIED SECTION
MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet
Marlex Pharmaceuticals, Inc.
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.
Magnesium Oxide Tablets
- ACTIVE INGREDIENT (In each tablet)
Ask a doctor if you have
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Antacids may interact with certain prescription drugs.
Do not take
more than 2 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks, except under the advise and supervision of a physician
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
magnesium oxide tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-583 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 400 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code 174 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10135-583-62 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 02/01/2019 Labeler - Marlex Pharmaceuticals Inc (782540215)