Foltanx

Basic Information

Product Label

Full Name: Foltanx

Brand: Breckenridge Pharmaceutical none

Product Type: Vitamin

Physical State: Tablet or Pill

UPC/SKU: 3 51991 81390 3

Product Version Code: Iss. 09/12 PC0222-00

Contact Information

Distributed by:

Name: Breckenridge Pharmaceutical, Inc.

Address:Boca Raton, FL, 33487

Types: Distributor

Manufactured by:

Name: Pamlab, LLC

Address:2008 Claiborne Avenue, Shreveport, LA, 71103

Types: Manufacturer

Product Details

Net Contents

90 Tablet(s)(90 Tablet(s))

Serving Sizes

Unit:Round Coated Purple Colored Tablet(s)

Quantity:1 - 1

Daily Servings:2 - 2

Target Groups

Adult (18 - 50 Years)Gluten FreeSugar Free

Ingredients & Nutrition

L-Methylfolate Calcium

vitamin

Amount: 3 mg

Serving Size: 1 Round Coated Purple Colored Tablet(s)

Group: Vitamin B9 (5-Methyltetrahydrofolate)

Also known as: Metafolin

UNII Code: A9R10K3F2F

Methylcobalamin

vitamin

Amount: 2 mg

Serving Size: 1 Round Coated Purple Colored Tablet(s)

Group: Vitamin B12 (methylcobalamin)

UNII Code: BR1SN1JS2W

Pyridoxal 5-Phosphate

vitamin

Amount: 35 mg

Serving Size: 1 Round Coated Purple Colored Tablet(s)

Group: Vitamin B6

Also known as: P-5-P, P5P

UNII Code: F06SGE49M6

Carnauba Wax

non-nutrient/non-botanical

Group: Carnauba wax

Dibasic Calcium Phosphate

mineral

Group: Calcium

UNII Code: L11K75P92J

silicified Microcrystalline Celluloses

other

Group: Cellulose

Product Statements

Formula re: Contains

Metafolin (L-methylfolate calcium) is a substantially diastereoisomerically pure source of L-methylfolate containing not more than 1% D-methylfolate which result in not more than 0.03 milligrams of D-methylfolate in Foltanx.

General Statements: All Other Content

See package insert for complete product information.

Formulation re: Does NOT Contain

Foltanx tablets do not contain sugar, lactose, yeast or gluten.

Brand IP Statement(s) re: (c), (TM), (SM)

Exclusive Authorized Generic: Breckenridge Pharmaceutical, Inc. is the exclusive authorized-generic distributor for all Metafolin containing brand products developed and distributed by Pamlab, Inc.

General Statements: All Other Content

51991-813-90

Precautions re: All Other

Do not use this product if the inner safety seal under the cap is torn, broken or missing.

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

FDA Statement of Identity

Medical Food

Suggested/Recommended/Usage/Directions

Dosage: One (1) tablet twice daily

Storage

Storage: Store at 25(0)C (77(0)F); excursions permitted to 15(0)C-30(0)C (59(0)F-86(0)F). See USP Controlled Room Temperature. Protect from heat, light and moisture.