Magnesium Oxide Tablets

Drug Facts

Composition & Product

Active Ingredients

Magnesium Cation (400 mg)

Inactive Ingredients

Croscarmellose Sodium Cellulose, Microcrystalline Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: AP;136 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2016-02-01

Medication Information

Purpose

Antacid

Description

Magnesium Oxide 400mg (241.2mg elemental magnesium)

Uses

Relieves: ■ acid indigestion ■ upset stomach

Directions

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

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 advise and supervision of a physician. May have a laxative effect.

Other Information

■ 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: 253 mg

Inactive Ingredients

croscarmellose sodium, microcrystalline cellulose, magnesium stearate

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Repackaging Information

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:

Count	400 mg
90	71610-172-60

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:

Cookeville, TN 38506

20181025JH

Ask A Doctor If You Have:

kidney disease

If Pregnant Or Breast Feeding,

ask a health professional before use.

Principal Display Panel 400 Mg

NDC 71610-172 - Magnesium Oxide 400 mg

Active Ingredient (in Each Tablet)

Magnesium Oxide 400mg (241.2mg elemental magnesium)

Ask A Doctor Or Pharmacist Before Use If You Are:

taking a prescription drug. Antacids may interact with certain prescription drugs.

Structured Label Content

Uses (USES)

Relieves: ■ acid indigestion ■ upset stomach

Purpose

Antacid

Directions (DIRECTIONS)

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

Do Not Take (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 advise and supervision of a physician. May have a laxative effect.

Other Information (OTHER INFORMATION)

■ 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: 253 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

croscarmellose sodium, microcrystalline cellulose, magnesium stearate

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Repackaging Information

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:

Count	400 mg
90	71610-172-60

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:

Cookeville, TN 38506

20181025JH

Ask A Doctor If You Have: (Ask a doctor if you have:)

kidney disease

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Principal Display Panel 400 Mg (PRINCIPAL DISPLAY PANEL - 400 mg)

NDC 71610-172 - Magnesium Oxide 400 mg

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (In each tablet))

Magnesium Oxide 400mg (241.2mg elemental magnesium)

Ask A Doctor Or Pharmacist Before Use If You Are: (Ask a doctor or pharmacist before use if you are:)

taking a prescription drug. Antacids may interact with certain prescription drugs.

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": "MAGNESIUM STEARATE", "unii": "70097M6I30", "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)

{"USES": "Relieves: ■ acid indigestion ■ upset stomach", "Purpose": "Antacid", "DIRECTIONS": "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", "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 advise and supervision of a physician. May have a laxative effect.", "OTHER INFORMATION": "■ 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: 253 mg", "INACTIVE INGREDIENTS": " croscarmellose sodium, microcrystalline cellulose, magnesium stearate", "Questions or Comments": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday", "Repackaging Information": "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: Count 400 mg 90 71610-172-60 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: Cookeville, TN 38506 20181025JH", "Ask a doctor if you have:": "kidney disease", "If pregnant or breast-feeding,": "ask a health professional before use.", "PRINCIPAL DISPLAY PANEL - 400 mg": "NDC 71610-172 - Magnesium Oxide 400 mg", "ACTIVE INGREDIENT (In each tablet)": "Magnesium Oxide 400mg (241.2mg elemental magnesium)", "Ask a doctor or pharmacist before use if you are:": "taking a prescription drug. Antacids may interact with certain prescription drugs."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information