FDA.reportPublic FDA data

Magnesium Oxide Tablets

Manufacturer
State of Florida DOH Central Pharmacy
Effective date
2013-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:59

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) (do not use if imprinted safety seal under cap is broken or missing (Magnesium content per tablet: 240 mg

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image for 400mg

Label Image for 400mg
Label Image for 400mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198741magnesium oxide 400 MG Oral TabletPSN1
198741magnesium oxide 400 MG Oral TabletSCD1
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0684-12020-01-31C16284748780-19d75b9d1-2ac0-f424-e053-dadaa90a57ceMagnesium Oxide Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0684-1Magnesium Oxide30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0684MAGNESIUM OXIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_b9d11379-a86d-4cc5-bbe4-8444db7bce5a.zip

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
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
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
53808-068453808-0684-1
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
COLLOIDAL SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

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
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 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
0db574c6-0270-4fbc-af7d-19cfdcc88e7cb9d11379-a86d-4cc5-bbe4-8444db7bce5a2013-09-25WarningsExact identifier
spl id: 0db574c6-0270-4fbc-af7d-19cfdcc88e7c
spl set id: b9d11379-a86d-4cc5-bbe4-8444db7bce5a

Reported adverse events (FAERS/openFDA)#

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