FDA.reportPublic FDA data

Magnesium Oxide Tablets

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2018-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:13

Label at a glance#

ProductMagnesium Oxide
Active ingredientMAGNESIUM OXIDE
Label structure8 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#

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:

OTC - ASK DOCTOR SECTION

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

SPL UNCLASSIFIED SECTION

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. May have a laxative effect.

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

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

SPL UNCLASSIFIED SECTION

■ store at room temperature 59°-86° F (15°-30°C) ■ do not use if imprinted safety seal under cap is broken or missing

■ Magnesium content per tablet: 240 mg

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count400 mg
9071610-182-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20181107JH

PRINCIPAL DISPLAY PANEL - 400 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-182 - Magnesium Oxide 400 mg - Rx Only
Bottle Label 400 mgBottle Label 400 mg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-182-60Magnesium Oxide90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-182MAGNESIUM OXIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20181114_11b2ce71-61fd-4e75-a859-a260b1dda080.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-182-60EA - Each71610-18270212216-02b8-43be-a4a5-89608b0d1b7a12019-01-24
0603-0209-22EA - Each0603-0209de9bb288-5b61-49a3-918e-60f3a72fa69312013-02-13

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
71610-18271610-182-60
0603-0209

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 OXIDE3A3U0GI71GACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
ndc (product): 0603-0209
Magnesium OxideMAGNESIUM OXIDEAphena Pharma Solutions - Tennessee, LLC11b2ce71-61fd-4e75-a859-a260b1dda0802018-11-07WarningsExact identifier
ndc (package): 71610-182-60
ndc (product): 71610-182
ndc11 (package): 71610018260
spl id: 1c7508c2-75cf-41b4-9172-89f4e7054368
spl set id: 11b2ce71-61fd-4e75-a859-a260b1dda080

Reported adverse events (FAERS/openFDA)#

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