Magnesium Oxide
FDA Label NDC 53808-0684

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Magnesium Oxide (NDC 53808-0684). 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 ingredients, purposes, uses, do not use, ask a doctor if you have:, ask a doctor/pharmacist before use if you are:, pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purposes

Antacid

Uses

Relieves: (acid indigestion (upset stomach

Do Not Use

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 advice and supervision of a physician. May have a laxative effect.

Ask A Doctor If You Have:

Kidney disease

Ask A Doctor/Pharmacist Before Use If You Are:

Taking a prescription drug. Antacids may interact with certain prescription drugs.

Pregnancy Or Breast Feeding

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

Package Label

Label Image for 400mg

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