Magnesium Oxide Tablets

Set ID
395601f7-a8e8-48d8-b1e0-7fad496ef461
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:08

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT (In each tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Uses

USES

relieves acid indigestion upset stomach

Warnings

WARNINGS

Directions And Dosage

DIRECTIONS

take 1 tablet twice a day or as directed by a physician

Other Label Information

OTHER INFORMATION

Magnesium content per tablet: 241.3mg store at room temperature 59°-86° F (15°-30°C)

INACTIVE INGREDIENTS

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

Questions or comments?

1-888-333-9792

PDP

Cabinet: Antacid Magnesium Oxide 400mg 75 Tablets

Products

NDC Codes

Ingredients

NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
MAGNESIUM OXIDE3A3U0GI71GACTIB

Complete SPL Sections

ACTIVE INGREDIENT (In each tablet)

OTC - ACTIVE INGREDIENT SECTION

Magnesium Oxide 400mg (241.3mg elemental magnesium)

USES

INDICATIONS & USAGE SECTION

relieves acid indigestion upset stomach

WARNINGS

WARNINGS SECTION

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

take 1 tablet twice a day or as directed by a physician

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Magnesium content per tablet: 241.3mg store at room temperature 59°-86° F (15°-30°C)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cabinet: Antacid Magnesium Oxide 400mg 75 Tablets

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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XML bytes
18420

Legacy File Index

FolderFileDate
otc292debac-ef73-5dde-e063-6294a90a25cf.xml2024-12-15
otc0bf02249-f336-3752-e063-6394a90a171e.xml2023-12-08
otcd2067606-c61a-fa0c-e053-2a95a90ab648.xml2021-12-01
otca9791f76-0c85-f7c5-e053-2995a90a5538.xml2020-07-03
otcUntitled.jpg2020-07-03