FDA Label for Magnesium Oxide
View Indications, Usage & Precautions
Magnesium Oxide Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Magnesium Oxide 400mg (241.2mg elemental magnesium)
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: 253 mg
Inactive Ingredients
croscarmellose sodium, microcrystalline cellulose, magnesium stearate
Questions Or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
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 | 71610-172-60 |
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:
Cookeville, TN 38506
20181025JH
Principal Display Panel - 400 Mg
NDC 71610-172 - Magnesium Oxide 400 mg
* Please review the disclaimer below.