L-Methyl-B6-B12 (Page 2 of 2)

PREGNANCY and NURSING MOTHERS

L-Methyl-B6-B12 is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.

Adverse Reactions to L-Methyl-B6-B12

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 .

DOSAGE AND ADMINISTRATION

One tablet twice daily or as directed by a licensed medical practitioner.

HOW SUPPLIED

L-Methyl-B6-B12 tablets are coated, round, purple tablets debossed with “BP 0.3″ on top and a bisect on bottom, and are supplied in bottles of 90 tablets and 500 tablets.

NDC 2 76439-218 -90 (90 ct. bottle / 90 tablets)
NDC 2 76439-218 -50 (500 ct. bottle / 500 tablets)


2
This product is a dietary supplement that – due to increased folate levels (AUG 2 1973 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

Rev. 2/2012

PRINCIPAL DISPLAY PANEL — 90 Tablet Bottle Label

VIRTUS
PHARMACEUTICALS

NDC 76439-218 -90

L-METHYL-B6-B12

TABLETS Prescription Dietary Supplement

Rx 90 Tablets

PRINCIPAL DISPLAY PANEL -- 90 Tablet Bottle Label
(click image for full-size original)
L-METHYL-B6-B12
levomefolate calcium, pyridoxal 5-phosphate, and methylcobalamin tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76439-218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Levomefolate Calcium (Levomefolic Acid) Levomefolate Calcium 15 mg
Pyridoxal 5-Phosphate (Pyridoxal 5-Phosphate) Pyridoxal 5-Phosphate 35 mg
Methylcobalamin (Methylcobalamin) Methylcobalamin 2 mg
Inactive Ingredients
Ingredient Name Strength
Croscarmellose sodium
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
calcium phosphate, dibasic, anhydrous
Silicon Dioxide
stearic acid
FD&C YELLOW NO. 6
ALUMINUM OXIDE
polyethylene glycols
polyvinyl alcohol
talc
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code BP;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76439-218-90 90 TABLET, COATED in 1 BOTTLE None
2 NDC:76439-218-50 500 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/15/2012
Labeler — Virtus Pharmaceuticals (969483143)

Revised: 08/2012 Virtus Pharmaceuticals

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.