FDA.reportPublic FDA data

MAGNESIUM OXIDE

Manufacturer
H. J. Harkins Company Inc.
Effective date
2017-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:11

Label at a glance#

ProductMAGNESIUM OXIDE
Active ingredientMAGNESIUM OXIDE
Label structure9 sections

Dosage and administration

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

Storage and 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)

Purpose

OTC - PURPOSE SECTION

relieves:

acid indigestion
upset stomach

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN 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.

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

DOSAGE & ADMINISTRATION SECTION

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

Storage & Handling

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

Indications & Usage

INDICATIONS & USAGE SECTION

Antacid

Warnings

WARNINGS SECTION

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

Package Label. Prinicpal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76519 1155.jpg76519 1155.jpg

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
76519-1155-62020-01-31C16284748780-19d75b9d1-0180-f424-e053-dadaa90a57ce60bb4830-2079-17eb-e053-2a91aa0a60ae

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1155-6MAGNESIUM OXIDE60 in 1 CONTAINERTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1155MAGNESIUM OXIDE TABLET [H. J. HARKINS COMPANY INC.]1Legacy NDC, 1 package rows20180410_60bb4830-2079-17eb-e053-2a91aa0a60ae.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
76519-115576519-1155-6

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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
60bb4830-207a-17eb-e053-2a91aa0a60ae60bb4830-2079-17eb-e053-2a91aa0a60ae2017-12-19WarningsExact identifier
spl id: 60bb4830-207a-17eb-e053-2a91aa0a60ae
spl set id: 60bb4830-2079-17eb-e053-2a91aa0a60ae

Reported adverse events (FAERS/openFDA)#

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