Active Ingredient (In Each Tablet)
Magnesium Oxide 400mg (241.3mg elemental magnesium)
Magnesium Oxide Tablet
FDA Label NDC 0603-0209
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 0603-0209). 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, ask a doctor if you have:, ask a doctor or pharmacist before use if you are:, do not take, if pregnant or breast-feeding,, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antacid
Uses
Relieves: ■ acid indigestion ■ upset stomach
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. May have a laxative effect.
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
■ store at room temperature 59°-86° F (15°-30°C) ■ do not use if imprinted safety seal under cap is broken or missing
■ Magnesium content per tablet: 240 mg
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid
Principal Display Panel
NDC 0603-0209-22
MAGNESIUM
OXIDE
TABLETS
400mg
240mg Elemental Magnesium Per Tablet
Magnesium Dietary Supplement and Antacid
Sugar and Gluten Free
120 Tablets
Qualitest®
Mfg for:
QUALITEST PHARMACEUTICALS, INC.
HUNTSVILLE, AL 35811 USA
LB0185
R0815
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