MAGNESIUM OXIDE- magnesium oxide tablet 
Virtus Pharmaceuticals 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 400 mg

241.3 mg Elemental Magnesium 19.86 mEq

No sugar, gluten, yeast, corn, wheat, milk, artificial colors, flavors or preservative added.

Dietary Supplement

SUPPLEMENT FACTS
*
Percent daily value according to USRDI.
Serving Size 1 Tablet
Servings per Container 120
Amount per Serving% Daily Value*
Magnesium241.3 mg60%
(from 400 mg of Magnesium Oxide

OTHER INGREDIENTS: Microcrystalline Cellulose, Sodium Starch Glycolate, and Stearic Acid.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DRUG INTERACTION PRECAUTION: This product may interact with certain prescription drugs. If you are presently taking a prescription drug, do not take this product without checking with your physician or other health professional.

DIRECTIONS: Take 1 tablet daily as a dietary supplement, or as directed by your health care provider.

DESCRIPTION: Each round, white tablet is imprinted "T" on one side and plain on the other.

WARNING: Not recommended for use in amounts over the recommended daily intake at 400 mg of elemental magnesium per day. Consult a physician before using this product if you have a kidney disease, or are pregnant or nursing a baby. May have a laxative effect.

STORAGE: Keep tightly closed in a dry place. Store at room temperature, 59° to 86° F (15° to 30° C).

IMPORTANT: For your protection, this bottle has an imprinted seal under the cap.

To report a Serious Adverse Event, call (813) 283-1344.

Manufactured for: Virtus Pharmaceuticals, LLC
Tampa, FL 33619 L-391
Rev. 04/13

PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

76439-217-12

Magnesium
Oxide 400 mg

241.3 mg Elemental Magnesium
19.86 mEq

No sugar, gluten, yeast, corn, wheat,
milk, artificial colors, flavors or
preservatives added.

Dietary Supplement

120 Tablets

VIRTUS
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label
MAGNESIUM OXIDE 
magnesium oxide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76439-217
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize11mm
FlavorImprint Code T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76439-217-12120 in 1 BOTTLE; Type 0: Not a Combination Product04/09/201410/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/09/201410/04/2016
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 10/2016
Document Id: f9b10655-74b4-4242-ae4b-c51debe3e2c0
Set id: 1ba0b4be-b4be-4033-8113-f984ea3c037c
Version: 3
Effective Time: 20161005
 
Virtus Pharmaceuticals LLC