FDA.reportPublic FDA data

Magnesium Oxide Tablets

Manufacturer
Safecor Health, LLC
Effective date
2012-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:55

Label at a glance#

ProductMagnesium Oxide
Active ingredientMAGNESIUM OXIDE
Label structure7 sections

Indications and uses

Relieves: acid indigestion, upset stomach

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purposes

OTC - PURPOSE SECTION

Antacid

USES

INDICATIONS & USAGE SECTION

Relieves: acid indigestion, upset stomach

WARNINGS

WARNINGS SECTION

Do Not Use

OTC - DO NOT USE SECTION

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:

OTC - ASK DOCTOR SECTION

Kidney disease

Ask a Doctor/Pharmacist before use if you are:

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

store at room temperature 59°-86° F (15°-30°C) , Magnesium content per tablet: 240 mg

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Magnesium Oxide 400 mg Robot Unit Dose Box Label
Magnesium Oxide 400 mg Robot Unit Dose Box Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-0209-22EA - Each0603-0209de9bb288-5b61-49a3-918e-60f3a72fa69312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71G1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48433-30248433-302-01, 48433-302-10
0603-0209

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM OXIDE3A3U0GI71GACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
ndc (product): 0603-0209
283657c8-ccba-49aa-b6e8-aed017315c07640680ef-b856-467f-bbaf-1144b290d75d2019-11-23WarningsExact identifier
spl set id: 640680ef-b856-467f-bbaf-1144b290d75d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.