FDA.reportPublic FDA data

Magnesium Oxide 400 mg Tablets

Manufacturer
APNAR PHARMA LP | INVAHEALTH INC | APNAR PHARMA LLP
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:10

Label at a glance#

ProductMagnesium Oxide
Active ingredientMAGNESIUM OXIDE
Label structure11 sections

Storage and handling

Other information Magnesium content per tablet : 241.3 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)

Magnesium Oxide 400 mg (241.3 mg elemental magnesium)

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses

relieves

  • acid indigestion
  • upset stomach

WARNINGS SECTION

Warnings

Ask a doctor before use if you have kidney disease

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacid 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 advice and supervision of a physician

If pregnant or breast-feeding, ask a professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Directions

Antacid Directions: take 1 tablet twice a day or as directed by a physician

Magnesium Supplement Directions: take 1 or 2 tablets day or as directed by a physician

STORAGE AND HANDLING SECTION

Other information

  • Magnesium content per tablet : 241.3 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 INGREDIENT SECTION

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, maize starch

OTC - QUESTIONS SECTION

Questions or comments?

1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 04/2022

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24689-132-01

Magnesium Oxide Tablets 400 mg

241.3 mg elemental Magnesium per tablet

Dietary supplement, Antacid

120 Tablets

Magnesium Oxide 400mg Tablets labelMagnesium Oxide 400mg Tablets label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198741magnesium oxide 400 MG Oral TabletPSN2
198741magnesium oxide 400 MG Oral TabletSCD2
198741magnesium oxide 400 MG (magnesium 241.3 MG) Oral TabletSY2

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
24689-132-01Magnesium Oxide120 in 1 BOTTLETABLET1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24689-132MAGNESIUM OXIDE TABLET [APNAR PHARMA LP]2Current NDC, Legacy NDC, 1 package rows20231021_e4ef2224-07e4-e913-e053-2995a90a28ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24689-132-01EA - Each24689-132b1f19fc5-b88f-4678-9686-a6ed3921d4aa12022-11-07

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
24689-13224689-132-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM OXIDE3A3U0GI71GACTIB
STARCH, CORNO8232NY3SJIACT

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
Magnesium OxideMAGNESIUM OXIDEAPNAR PHARMA LPe4ef2224-07e4-e913-e053-2995a90a28ed2023-10-21WarningsExact identifier
ndc (package): 24689-132-01
ndc (product): 24689-132
ndc11 (package): 24689013201
spl id: 08353d99-4377-eb64-e063-6294a90aa949
spl set id: e4ef2224-07e4-e913-e053-2995a90a28ed