FDA.reportPublic FDA data

Magnesium Oxide Tablets

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:08

Label at a glance#

ProductMagnesium Oxide 400mg
Active ingredientMAGNESIUM OXIDE
Label structure8 sections

Indications and uses

relieves acid indigestion upset stomach

Dosage and administration

take 1 tablet twice a day or as directed by a physician

Storage and handling

Magnesium content per tablet: 241.3mg store at room temperature 59°-86° F (15°-30°C)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (In each tablet)

OTC - ACTIVE INGREDIENT SECTION

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

OTC - PURPOSE SECTION

Antacid

USES

INDICATIONS & USAGE SECTION

relieves

  • acid indigestion
  • upset stomach

WARNINGS

WARNINGS SECTION

Ask a doctor if you have

OTC - ASK DOCTOR SECTION

kidney disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Do not take

SPL UNCLASSIFIED SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • take 1 tablet twice a day or as directed by a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Magnesium content per tablet: 241.3mg
  • store at room temperature 59°-86° F (15°-30°C)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cabinet:

Antacid

Magnesium Oxide 400mg

75 Tablets

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198741magnesium oxide 400 MG Oral TabletPSN5
198741magnesium oxide 400 MG Oral TabletSCD5
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY5

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
68210-4105-12023-12-07C16284748780-1f386c64a-0e60-0266-e053-dadaa90a7c1aMagnesium Oxide Tablets
68210-4105-12023-01-30C16284748780-1f386c64a-0e60-0266-e053-dadaa90a7c1aMagnesium Oxide Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4105-1Magnesium Oxide 400mg75 in 1 BOTTLETABLET755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4105MAGNESIUM OXIDE 400MG TABLET [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20241215_395601f7-a8e8-48d8-b1e0-7fad496ef461.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-410568210-4105-1

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM OXIDE3A3U0GI71GACTIB

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
292debac-ef73-5dde-e063-6294a90a25cf395601f7-a8e8-48d8-b1e0-7fad496ef4612024-12-13WarningsExact identifier
spl id: 292debac-ef73-5dde-e063-6294a90a25cf
spl set id: 395601f7-a8e8-48d8-b1e0-7fad496ef461

Reported adverse events (FAERS/openFDA)#

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