FDA.reportPublic FDA data

Magnesium Oxide

Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-24
Label type
HUMAN OTC DRUG LABEL
Version
105
Source
full-release
Hydrated at
2026-06-01 01:54:54

Label at a glance#

ProductMagnesium Oxide
Active ingredientMAGNESIUM OXIDE
Label structure11 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Magnesium Oxide 400 mg

(241.3 mg Elemental Magnesium)

Purpose

OTC - PURPOSE SECTION

Antacid

Use

INDICATIONS & USAGE SECTION

relieves: ■ acid indigestion ■ upset stomach

Warnings

WARNINGS SECTION

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

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.

Questions?

OTC - QUESTIONS SECTION

Call Method at 1-877-250-3427 or FDA at 1-800-FDA-1088

Manufactured for:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118

Rev. 04/18

HOW SUPPLIED

How Supplied Section

Magnesium Oxide 400mg Tablets

  • NDC 63629-9420-1: 120 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Magnesium Oxide 400mg Tablets

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198741magnesium oxide 400 MG Oral TabletPSN105
198741magnesium oxide 400 MG Oral TabletSCD105
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY105

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codedailymed.nlm.nih.gov/dailymed/search.cfm?query=63629-9420-1lbl636299420.jpg
Data codeCode 1286362994201lbl636299420.jpg
Data codeData Matrix lbl636299420.jpg

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
63629-9420-1Magnesium Oxide120 in 1 BOTTLETABLET120105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9420-1EA - Each63629-9420da066584-4b85-40f9-a4cb-a67eef3aba7612022-09-12
58657-120-12EA - Each58657-120dccb36af-6ab1-4ff2-8c9a-629be7f1e7c812018-09-05

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
63629-942063629-9420-1
58657-120

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
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepack77fa8fe5-33ac-44b2-9596-5b276e9f21622026-04-24WarningsExact identifier
ndc (package): 63629-9420-1
ndc (product): 63629-9420
ndc11 (package): 63629942001
spl id: 1e5d69cd-f8c2-4469-8c72-aa864c53bd19
spl set id: 77fa8fe5-33ac-44b2-9596-5b276e9f2162
Magnesium OxideMAGNESIUM OXIDEMethod Pharmaceuticals, LLC0af63651-f9d9-43b9-b6f0-4878466a82e62025-10-21WarningsExact identifier
ndc (product): 58657-120

Reported adverse events (FAERS/openFDA)#

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