Active Ingredient (In Each Tablet)
Magnesium Oxide 400mg (241.3mg elemental magnesium)
Magnesium Oxide Tablet
FDA Label NDC 71610-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Magnesium Oxide (NDC 71610-182). 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
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 400 mg |
| 90 | 71610-182-60 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Aphena Pharma Solutions (TN)
Cookeville, TN 38506
20181107JH
Principal Display Panel - 400 Mg
NDC 71610-182 - Magnesium Oxide 400 mg - Rx Only
Bottle Label 400 mg (71610 0182 60)
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