MAGNESIUM OXIDE- magnesium oxide tablet 
Aphena Pharma Solutions - Tennessee, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Magnesium Oxide Tablets

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:

Count400 mg
9071610-182-60

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:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20181107JH

PRINCIPAL DISPLAY PANEL - 400 mg

NDC 71610-182 - Magnesium Oxide 400 mg - Rx Only
Bottle Label 400 mg

MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-182(NDC:0603-0209)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 174
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-182-6090 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/03/2003
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-182)

Revised: 11/2018
Document Id: 1c7508c2-75cf-41b4-9172-89f4e7054368
Set id: 11b2ce71-61fd-4e75-a859-a260b1dda080
Version: 1
Effective Time: 20181107
 
Aphena Pharma Solutions - Tennessee, LLC