Foltanx
Product Overview
Brand: Breckenridge Pharmaceutical
Barcode: 3 51991 81390 3
Net Contents: 90 Tablet(s)
Serving Size (Overview): 1 Round Coated Purple Colored Tablet(s)
Product Type: Vitamin [A1302]
Form: Tablet or Pill [E0155]
Date Entered: Feb 25, 2019
Market Status: On Market
Suggested Use (Overview): Dosage: One (1) tablet twice daily
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| L-Methylfolate Calcium | vitamin | 3 | mg | N/A | N/A | 1 Round Coated Purple Colored Tablet(s) |
| Pyridoxal 5-Phosphate | vitamin | 35 | mg | N/A | N/A | 1 Round Coated Purple Colored Tablet(s) |
| Methylcobalamin | vitamin | 2 | mg | N/A | N/A | 1 Round Coated Purple Colored Tablet(s) |
Other Ingredients
Dibasic Calcium Phosphate; silicified Microcrystalline Celluloses; Opadry II Purple 40L10045 (FD&C Blue No. 2 Aluminum Lake; Hypromelloses; PEG 8000; Polydextrose; Titanium Dioxide; Triacetin); Opadry II Clear Y-19-7483 (Hypromelloses; Maltodextrin; PEG 4000); Magnesium Stearate; Carnauba Wax
Label Statements
Formulation
- 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. Foltanx tablets do not contain sugar lactose yeast or gluten.
Other
- See package insert for complete product information. 51991-813-90
Branding Statement(s)
- Exclusive Authorized Generic:Breckenridge Pharmaceutical Inc. is the exclusive authorized-generic distributor for all Metafolin containing brand products developed and distributed by Pamlab Inc. Metafolin is a registered trademark of Merck KGaA Darmstadt Germany
Precautions
- Do not use this product if the inner safety seal under the cap is torn broken or missing. Warning: Keep this and all medications out of the reach of children.
Statement of Identity
- 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. Medical Food
Suggested Use
- Dosage: One (1) tablet twice daily
Product Specific Information
- 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.
Product/Version Code
- Iss. 09/12 PC0222-00
Associated Company Information & Roles
Breckenridge Pharmaceutical Inc.
Boca Raton,
FL
33487
Roles for this Product:
- Distributor
Pamlab LLC
2008 Claiborne Avenue,
Shreveport,
LA
71103
Roles for this Product:
- Manufacturer