Magnesium Oxide Tablets

Magnesium Oxide Tablets
SPL v1
SPL
SPL Set ID 11b2ce71-61fd-4e75-a859-a260b1dda080
Route
ORAL
Published
Effective Date 2018-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (400 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 174 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2003-12-03

Description

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

Antacid


Medication Information

Purpose

Antacid

Description

Magnesium Oxide 400mg (241.3mg 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: 240 mg

Inactive Ingredients

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

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 71610-182-60

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:



Cookeville, TN 38506



20181107JH

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 71610-182 - Magnesium Oxide 400 mg - Rx Only

Active Ingredient (in Each Tablet)

Magnesium Oxide 400mg (241.3mg 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: 240 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

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

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 71610-182-60

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:



Cookeville, TN 38506



20181107JH

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 71610-182 - Magnesium Oxide 400 mg - Rx Only

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

Magnesium Oxide 400mg (241.3mg 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


Raw Label Data

All Sections (JSON)