FDA.reportPublic FDA data

Magnesium Oxide

Manufacturer
Wittman Pharma, Inc.
Effective date
2024-04-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:10:54

Label at a glance#

ProductMagnesium Oxide
Active ingredientMAGNESIUM OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Tablet taken Orally

Do not take more than 2 tablets in a 24 hour period

WARNINGS SECTION

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

INACTIVE INGREDIENT SECTION

Microcrystaline Cellulose,

Sodium Starch Glycolate,

Stearic Acid

INDICATIONS & USAGE SECTION

relieves acid indigestion and upset stomach

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

Antacid

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTIVE INGREDIENT (In each tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

Antacid

USES

relieves - acid indigestion - upset stomach

WARNINGS

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.

DIRECTIONS

take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.

OTHER INFORMATION

Magnesium content per tablet: 241.3mg

store at room temperature 59°- 86° F (15°- 30°C)

INACTIVE INGREDIENTS

microcrystalline cellulose, sodium starch, glyocolate, stearic acid

Questions?

1-352-549-9917 M-F 9am - 5pm EST

Mag LabelMag Label

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
83335-001-122025-07-29C16284748780-13b156c62-2e01-fb37-e063-e6dba90a4e07Mag Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83335-001-12Magnesium Oxide120 mg in 1 BOTTLE, PLASTICTABLET1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83335-001MAGNESIUM OXIDE TABLET [WITTMAN PHARMA, INC.]51 package rows20240410_f7064d17-04b1-160b-e053-6394a90ad8be.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83335-00183335-001-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM OXIDE3A3U0GI71GACTIM

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
1547fd77-3c10-152a-e063-6394a90a8688f7064d17-04b1-160b-e053-6394a90ad8be2024-04-04WarningsExact identifier
spl id: 1547fd77-3c10-152a-e063-6394a90a8688
spl set id: f7064d17-04b1-160b-e053-6394a90ad8be

Reported adverse events (FAERS/openFDA)#

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