Magnesium Oxide
FDA Label NDC 10135-583

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Magnesium Oxide (NDC 10135-583). 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 ingredient (in each tablet), purpose, uses, warnings, ask a doctor or pharmacist before use if you are, if pregnant or breast-feeding,, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

Antacid

Uses

  • relieves
  • acid indigestion upset stomach

Warnings

Ask a doctor if you have

kidney disease

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions

Antacid Directions:

  • take 1 tablet twice a day or as directed by a physician

    • Magnesium Supplement Directions:

    • take 1 to 2 tablets daily or as directed by a physician

Other Information

  • Magnesium content per tablet: 241.3mg
  • store at room temperature 59°-86° F (15°-30°C)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid

Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Made in the U.S.A.

Rev. 02/19AH

Principal Display Panel

NDC 10135-0583-62
Magnesium Oxide
400 mg
120 TABLETS

Principal Display Panelndc 10135-0583-62magnesium Oxide400 mg120 Tablets (Magnesium Oxide 01)

Principal Display Panelndc 10135-0583-62magnesium Oxide400 mg120 Tablets (Magnesium Oxide 01)

Principal Display Panelndc 10135-0583-62magnesium Oxide400 mg120 Tablets (Magnesium Oxide 02)

Principal Display Panelndc 10135-0583-62magnesium Oxide400 mg120 Tablets (Magnesium Oxide 02)

* Please review the disclaimer below.