Active Ingredient
Magnesium Oxide 400 mg
(241.3 mg Elemental Magnesium)
Magnesium Oxide Tablet
FDA Label NDC 58657-120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product Magnesium Oxide (NDC 58657-120). 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, purpose, use, ask a doctor before use if, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Use
relieves: ■ acid indigestion ■ upset stomach
Ask A Doctor Before Use If
- you have kidney disease
- you are taking a prescription drug (antacids may interact with certain prescription drugs)
- you are pregnant or breast feeding.
- May have a laxative effect.
Do not take more than 2 tablets in a 24 hour period.
Directions
- take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.
Other Information
- Store at controlled room temperature 15° to 30°C (59° to 86°F).
- Tamper evident, do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredients
Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.
Questions?
Call Method at 1-877-250-3427 or FDA at 1-800-FDA-1088
Manufactured for:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118
Rev. 04/18
Principal Display Panel
NDC 58657-120-12
Magnesium Oxide
400 mg
241.3 Elemental Magnesium
Antacid
120 Tablets
Ndc 58657-120-12magnesium Oxide400 mg241.3 Elemental Magnesium Antacid120 Tablets (Magnesium Oxide 01)
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