Magnesium Oxide

SPL v7

SPL

SPL Set ID 0af63651-f9d9-43b9-b6f0-4878466a82e6

Route

ORAL

Published

Effective Date 2018-07-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Magnesium Cation (400 mg)

Inactive Ingredients

Croscarmellose Sodium Cellulose, Microcrystalline Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 120 Shape: round Color: white Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-07-25

Description

Drug Facts

Purpose

Antacid

Medication Information

Purpose

Antacid

Description

Drug Facts

Use

relieves: ■ acid indigestion ■ upset stomach

Section 42229-5

Drug Facts

Directions

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

Questions?

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

Active Ingredient

Magnesium Oxide 400 mg

(241.3 mg Elemental Magnesium)

Other Information

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

Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

Principal Display Panel

NDC 58657-120-12

Magnesium Oxide

400 mg

241.3 Elemental Magnesium

Antacid

120 Tablets

Ask A Doctor Before Use If

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.

Structured Label Content

Use

relieves: ■ acid indigestion ■ upset stomach

Section 42229-5 (42229-5)

Drug Facts

Purpose

Antacid

Directions

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

Questions?

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

Active Ingredient (Active ingredient)

Magnesium Oxide 400 mg

(241.3 mg Elemental Magnesium)

Other Information (Other information)

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 ingredients)

Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.

Principal Display Panel

NDC 58657-120-12

Magnesium Oxide

400 mg

241.3 Elemental Magnesium

Antacid

120 Tablets

Ask A Doctor Before Use If (Ask a doctor before use if)

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.

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "relieves: ■ acid indigestion ■ upset stomach", "42229-5": "Drug Facts", "Purpose": "Antacid", "Directions": "take one or two antacid tablets daily. Do not exceed two tablets unless directed by a physician.", "Questions?": "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", "Active ingredient": "Magnesium Oxide 400 mg (241.3 mg Elemental Magnesium)", "Other information": "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": "Croscarmellose Sodium, Microcrystalline Cellulose, Silicon Dioxide, and Stearic Acid.", "Principal Display Panel": "NDC 58657-120-12 Magnesium Oxide 400 mg 241.3 Elemental Magnesium Antacid 120 Tablets", "Ask a doctor before use if": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:31.504039 · Updated: 2026-03-14T23:13:16.476899