Active Ingredients
Magnesium Oxide 420mg (253mg elemental magnesium per tablet)
Magnesium Oxide Tablet
FDA Label NDC 0603-0213
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Endo Usa for the product Magnesium Oxide (NDC 0603-0213). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, uses, purposes, warnings, pregnancy or breast feeding, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
As a dietary supplement.
Purposes
Magnesium Oxide may help in magnesium deficiencies.†
Warnings
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. If pregnant or breast-feeding, ask a health professional before use.
Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Directions
Take one tablet daily or as directed by a physician.
Other Information
This product is sealed for your protection. Do not use if imprinted safety seal under cap is broken or missing. Keep tightly closed and store in a cool, dry place.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid.
Principal Display Panel
†These statements have not been evaluated by The Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure or prevent any disease.
Manufactured for:
Qualitest Pharmaceuticals
130 Vintage Drive
Huntsville, AL 35811 USA
* Please review the disclaimer below.
