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Magnesium oxide - Medication Information

Product NDC Code 0603-0213
Drug Name

Magnesium oxide

Type Generic
Pharm Class Calculi Dissolution Agent [EPC],
Increased Large Intestinal Motility [PE],
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],
Magnesium Ion Exchange Activity [MoA],
Osmotic Activity [MoA],
Osmotic Laxative [EPC],
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
Active Ingredients
Magnesium oxide 253 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 311430
Application Number M001
Labeler Name Endo USA
Packages
Package NDC Code Description
0603-0213-21 100 tablet in 1 bottle (0603-0213-21)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient(s) Magnesium Oxide

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Take one tablet daily or as directed by a physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use(s) As a dietary supplement.

Purpose

Information about the drug product’s indications for use.
Purpose Magnesium Oxide may help in magnesium deficiencies †

Spl product data elements

Usually a list of ingredients in a drug product.
Magnesium Oxide Magnesium Oxide MAGNESIUM OXIDE MAGNESIUM CATION SILICON DIOXIDE CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE STEARIC ACID 306

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Magnesium Oxide †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 Magnesium Oxide Magnesium Oxide

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Other information This product is sealed for your protection. Do not use if imprinted safety seal under cap is broken or missing.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children

Pregnancy or breast feeding

Pregnancy or Breast feeding
Pregnancy/Breastfeeding ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Storage Keep tightly closed and store in a cool, dry place.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings 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. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API