FDA.reportPublic FDA data

Magnesium Oxide

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2019-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:28

Label at a glance#

ProductMagnesium Oxide
Active ingredientMAGNESIUM OXIDE
Label structure9 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#

SPL UNCLASSIFIED SECTION

MAGNESIUM OXIDE 400MG- magnesium oxide 400mg tablet

Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Magnesium Oxide Tablets

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

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

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

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.

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

SAFE HANDLING WARNING SECTION

  • Magnesium content per tablet: 241.3mg
  • store at room temperature 59°-86° F (15°-30°C)
  • do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720

Made in the U.S.A.

Rev. 02/19AH

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0583-62
Magnesium Oxide
400 mg
120 TABLETS

PRINCIPAL DISPLAY PANEL NDC 10135-0583-62 Magnesium Oxide 400 mg 120 TABLETSPRINCIPAL DISPLAY PANEL NDC 10135-0583-62 Magnesium Oxide 400 mg 120 TABLETS

PRINCIPAL DISPLAY PANEL NDC 10135-0583-62 Magnesium Oxide 400 mg 120 TABLETSPRINCIPAL DISPLAY PANEL NDC 10135-0583-62 Magnesium Oxide 400 mg 120 TABLETS

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
10135-583-622021-01-29C16284748780-1ba0f9c33-2512-a910-e053-dadaa90a0b85Magnesium Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-583-62Magnesium Oxide120 in 1 BOTTLETABLET1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-583MAGNESIUM OXIDE TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20190206_ca0c1df9-1285-4131-99e8-4198adda3341.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-583-62EA - Each10135-5839ed46e85-5880-446a-bcb4-76c902899b6c12019-03-12

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
10135-58310135-583-62

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 OXIDE3A3U0GI71GACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

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
096293fe-3cc5-4c19-94c2-48d82872f023ca0c1df9-1285-4131-99e8-4198adda33412019-02-08WarningsExact identifier
spl id: 096293fe-3cc5-4c19-94c2-48d82872f023
spl set id: ca0c1df9-1285-4131-99e8-4198adda3341

Reported adverse events (FAERS/openFDA)#

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