pyridoxine hydrochloride tablet, coated
Breckenridge Pharmaceutical, Inc.
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.
Safety and effectiveness in pediatric patients have not been established.
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.
Adults - one tablet daily or as directed by a physician.
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.
Dispense in a tight, light-resistant container with a child-resistant closure, as defined in USP/NF.
Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from light and moisture.
Nexgen Pharma, Inc.
Irvine, CA 92614
Boca Raton, FL
7047 Rev. 11/08
Each Tablet Contains:
Folic Acid ........................... 2.2 mg
Vitamin B6 .......................... 25 mg
Vitamin B12 .......................... 1 mg
folic acid, cholecalciferol and pyridoxine hydrochloride tablet, coated
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|Labeler - Breckenridge Pharmaceutical, Inc. (150554335)|