FOLPLEX
-
folic acid,
cholecalciferol and
pyridoxine hydrochloride tablet, coated
Breckenridge Pharmaceutical, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Folplex™ tablets are intended for oral administration.
Each Tablet Contains: 2.2 mg folic acid, 25 mg Vitamin B6 and 1 mg Vitamin B12.
INACTIVE INGREDIENTS: Dibasic Calcium Phosphate, Microcrystalline Cellulose, Modified Cellulose Gum, Crospovidone, Magnesium Stearate, Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Polyethylene Glycol, Iron Oxide Red, Iron Oxide Yellow.
Folplex™ tablets are indicated for nutritional support and folic acid supplementation.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Folplex™ tablets are peach color coated oval-shaped tablets. Each tablet is imprinted with B 352 on the scored side and plain on the other side.
Folplex™ tablets are available in bottles of 100 tablets. NDC 51991-352-01
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Manufactured by:
Nexgen Pharma, Inc.
Irvine, CA 92614
Distributed by:
Breckenridge
Pharmaceutical, Inc.
Boca Raton, FL
33487
Rx Only
7047 Rev. 11/08
Breckenridge
Pharmaceutical, Inc.
NDC 51991-352-01
Folplex™
Each Tablet Contains:
Folic Acid ........................... 2.2 mg
Vitamin B6 .......................... 25 mg
Vitamin B12 .......................... 1 mg
Rx Only
100 Tablets
FOLPLEX
folic acid, cholecalciferol and pyridoxine hydrochloride tablet, coated |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
Unapproved drug other | 09/01/2006 | 10/31/2010 |
Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Nexgen Pharma | 160356114 | MANUFACTURE |
Revised: 06/2012 Breckenridge Pharmaceutical, Inc.