L-METHYL PNV DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxal 5-phosphate, levomefolate calcium, methylcobalamin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, selenium and crypthecodinium cohnii dha oil capsule capsule, gelatin coated 
Virtus Pharmaceuticals LLC

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L-Methyl PNV DHA

STATEMENT OF IDENTITY: L-Methyl PNV DHA is an orally administered prescription dietary supplement and should be administered under the supervision of a licensed medical practitioner.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

DOSAGE AND ADMINISTRATION: 1 capsule daily with or without food or as prescribed by a licensed medical practitioner regardless of lactation status.

*
Cas #151533-22-1
Vitamin C (as ascorbic acid)85 mg
Vitamin D3 (as cholecalciferol)5 mcg
Vitamin E (as d-alpha-tocopherol)15 mg
Vitamin B1 (as thiamine mononitrate) 1.4 mg
Vitamin B2 (as riboflavin)1.4 mg
Vitamin B3 (as niacinimide)18 mg
Vitamin B6 (as Pyridoxal 5' Phosphate)25 mg
L-Methylfolate Calcium*1.13 mg
Vitamin B12 (as methylcobalamin)1 mg
Calcium (as calcium carbonate)110 mg
Iron (as ferrous fumarate)27 mg
Iodide (as potassium iodide)220 mcg
Magnesium (as magnesium oxide)60 mg
Selenium60 mcg
Crypthecodinium cohnii dha oil581.92

Other Ingredients: Soybean Lecithin, Gelatin, Glycerin, Water, Rice Bran Oil, Beeswax, Titanium Dioxide, FD&C Blue #1, FD&C Red #40.

How Supplied: Supplied as a coated, blue capsule imprinted "327", dispensed in bottles of 90 capsules.

PRECAUTIONS/WARNING: Folic Acid may obscure pernicious anemia in that the peripheral blood picture may revert to normal while neurological manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid.

STORAGE: Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

HEALTH CLAIMS: Prescription Vitamin B9 Containing Dietary Supplement

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label

VIRTUS
PHARMACEUTICALS

76439-327-90

L-Methyl PNV DHA

PRENATAL/POSTNATAL

Prescription Vitamin B9-Containing
Dietary Supplement

Rx

90 Capsules       Made in the USA

PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
L-METHYL PNV DHA 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxal 5-phosphate, levomefolate calcium, methylcobalamin, calcium carbonate, ferrous fumarate, potassium iodide, magnesium oxide, selenium and crypthecodinium cohnii dha oil capsule capsule, gelatin coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76439-327
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID85 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL5 ug
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-15 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.4 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE18 mg
PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS25 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM1.13 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION110 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE220 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE60 mg
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM60 ug
Crypthecodinium cohnii dha oil (UNII: 8ZJ335A17J) (Crypthecodinium cohnii dha oil - UNII:8ZJ335A17J) Crypthecodinium cohnii dha oil581.92 mg
Inactive Ingredients
Ingredient NameStrength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
RICE BRAN OIL (UNII: LZO6K1506A)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:76439-327-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT08/12/201308/02/2014
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)19 mm
imprint
Labeler - Virtus Pharmaceuticals LLC (969483143)

Revised: 10/2017
 
Virtus Pharmaceuticals LLC