FDA.reportPublic FDA data

Mag 440

Manufacturer
Allegis Pharmaceuticals, LLC
Effective date
2025-04-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:16

Label at a glance#

ProductMag 440
Active ingredientMAGNESIUM OXIDE
Label structure10 sections

Indications and uses

Relieves: Acid indigestion and upset stomach

Dosage and administration

Antacid Directions : take 1 tablet trice a day or as directed by a Physician. Magnesium Supplement Directions : Take 1 or 2 tablets day or as directed by a Physician.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)..........................................................Purpose

Megnesium Oxide 440 mg (265.3 mg Elemental Magnesium).............Antacid

Uses

INDICATIONS & USAGE SECTION

Relieves: Acid indigestion and upset stomach

Warnings

WARNINGS SECTION

Ask a dcotor before use if you have kidney disease.

Ask a doctor or pharmacist before use if you are taking a presciption drug.

Antacid may interact with certian 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, ask a professional before use.

Keep out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Antacid Directions: take 1 tablet trice a day or as directed by a Physician.

Magnesium Supplement Directions: Take 1 or 2 tablets day or as directed by a Physician.

Other Information

OTHER SAFETY INFORMATION

Magnesium content per tablet: 265.3 mg

Store at controlled 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

Croscarmellose Sodium, Microcrystalline Cellulose, Stearic Acid, Megnesium Stearate, Coating composition: Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, PEG.

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-601-859-0038

How Supplied

HOW SUPPLIED SECTION

Manufactured For: Allegis Pharmaceuticals, LLC
Canton, MS 39046
www.allegispharma.com

Rev 12/2024

Purpose

OTC - PURPOSE SECTION

Purpose: Antacid

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2707337magnesium oxide 440 MG Oral TabletPSN3
2707337magnesium oxide 440 MG Oral TabletSCD3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28595-710-40Mag 44040 in 1 BOTTLETABLET403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-710MAG 440 (MEGNESIUM OXIDE) TABLET [ALLEGIS PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20250418_2cb19dc0-115b-38b8-e063-6294a90a4aea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-710-40EA - Each28595-710c2d507f7-8b42-44e0-8691-9847fb9a806412025-03-04

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
28595-71028595-710-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM STEARATE70097M6I30IACT
MAGNESIUM OXIDE3A3U0GI71GACTIM
HYDROXYPROPYL METHYLCELLULOSE3NXW29V3WOIACT
POLYETHYLENE GLYCOL 1000000HZ58M6D839IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
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
Mag 440MEGNESIUM OXIDEAllegis Pharmaceuticals, LLC2cb19dc0-115b-38b8-e063-6294a90a4aea2025-04-17WarningsExact identifier
ndc (package): 28595-710-40
ndc (product): 28595-710
ndc11 (package): 28595071040
spl id: 32fd7e5e-f1bd-85e9-e063-6294a90a876f
spl set id: 2cb19dc0-115b-38b8-e063-6294a90a4aea

Reported adverse events (FAERS/openFDA)#

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