Magnesium Oxide by Aphena Pharma Solutions - Tennessee, LLC MAGNESIUM OXIDE tablet

Magnesium Oxide by

Drug Labeling and Warnings

Magnesium Oxide by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (In each tablet)

Magnesium Oxide 400mg (241.3mg elemental magnesium)

Purpose

Antacid

USES

Relieves: ■ acid indigestion  ■ upset stomach

WARNINGS

Ask a doctor if you have:

kidney disease

Ask a doctor or pharmacist before use if you are:

taking a prescription drug. Antacids 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 advise and supervision of a physician. May have a laxative effect.

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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

PRINCIPAL DISPLAY PANEL - 400 mg

NDC: 71610-182 - Magnesium Oxide 400 mg - Rx Only

INGREDIENTS AND APPEARANCE

MAGNESIUM OXIDE 
magnesium oxide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-182(NDC:0603-0209)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	174
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-182-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part331	12/03/2003

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-182)