Active Ingredient
Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)
Magnesium Oxide
FDA Label NDC 76519-1155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H. J. Harkins Company Inc. for the product Magnesium Oxide (NDC 76519-1155). 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, keep out of reach of children, dosage and administration, storage & handling, inactive ingredients, indications & usage, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
relieves:
acid indigestion
upset stomach
Keep Out Of Reach Of Children
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.
Do not take more than 2 tablets in a 24 hour period.
May have a laxative effect.
Keep out of reach of children.
Dosage And Administration
take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.
Storage & Handling
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.
Indications & Usage
Antacid
Warnings
Do not take this product if you are presently taking a prescription drug without consulting your physician or other health care professional. If you have kidney disease, take only under the supervision of a physician. May have a laxative effect. If pregnant or breast-feeding, ask a health professional before use.
Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out of Reach of Children
* Please review the disclaimer below.
