L-Methyl MC (Page 2 of 2)

PREGNANCY and NURSING MOTHERS

L-Methyl-MC is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins. Talk with your medical practitioner before using L-Methyl-MC if pregnant or lactating.

Adverse Reactions to L-Methyl MC

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.

Paresthesia, somnolence, nausea, and headaches have been reported with vitamin B6 .

Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12 .

If headaches occur with the use of this product, consult your medical practitioner.

DOSAGE AND ADMINISTRATION

Usual adult dose is one to two tablets daily or as prescribed by a licensed medical practitioner. L-Methyl-MC is not recommended for use in children under the age of twelve.

HOW SUPPLIED

L-Methyl-MC is supplied as round, coated, blue tablets debossed “BP” on top and “850″ on bottom, dispensed in bottles of 90 tablets.

NDC 2 : 76439-207 -90


2
This product is a dietary supplement that due to increased folate levels (AUG 2, 1973 38 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

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.

Call your medical practitioner about side effects. You may report side effects by calling (813)-283-1344.

KEEP THIS OUT OF THE REACH OF CHILDREN.

Rx

Prescription Dietary Supplement
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
www.virtusRX.com
MADE IN USA

VIRTUS
PHARMACEUTICALS

REV 1/2012

PRINCIPAL DISPLAY PANEL — 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

NDC 76439-207 -90

L-METHYL-MC

TABLETS Prescription Dietary Supplement

Rx

90 Tablets

Made in the USA

PRINCIPAL DISPLAY PANEL -- 90 Tablet Bottle Label
(click image for full-size original)
L-METHYL MC
levomefolate calcium, riboflavin, cyanocobalamin, and pyridoxine tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-207
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levomefolate Calcium (Levomefolic Acid) Levomefolate Calcium 6 mg
Riboflavin (Riboflavin) Riboflavin 5 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 1 mg
Pyridoxine (Pyridoxine) Pyridoxine 50 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
calcium phosphate, dibasic, anhydrous
croscarmellose sodium
stearic acid
magnesium stearate
silicon dioxide
propylene glycol
polyethylene glycols
titanium dioxide
hydroxypropyl cellulose
FD&C blue no. 2
aluminum oxide
hypromelloses
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code BP;850
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76439-207-90 90 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/01/2012
Labeler — Virtus Pharmaceuticals (969483143)

Revised: 09/2012 Virtus Pharmaceuticals

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