Folplex

folic acid, cholecalciferol and pyridoxine hydrochloride

Dosage Form: tablet, coated
Folplex™

Description

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.

Indications and Usage

Folplex™ tablets are indicated for nutritional support and folic acid supplementation.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Warning

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.

Dosage and Administration

Adults - one tablet daily or as directed by a physician.

How Supplied

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.

Manufactured by:

Nexgen Pharma, Inc.

Irvine, CA 92614

Distributed by:

Breckenridge

Pharmaceutical, Inc.

Boca Raton, FL

33487

Rx Only

7047 Rev. 11/08

PRINCIPAL DISPLAY PANEL - 100 Tablets Bottle

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

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-352 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (Folic Acid) Folic Acid 2.2 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 1 mg Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 25 mg

Inactive Ingredients Ingredient Name Strength Dibasic Calcium Phosphate Dihydrate   Cellulose, Microcrystalline   Croscarmellose Sodium   Crospovidone   Magnesium Stearate   Hypromellose   Titanium Dioxide   Polydextrose   Triacetin   Polyethylene Glycol   Ferric Oxide Red   Ferric Oxide Yellow

Product Characteristics Color PINK Score 2 pieces Shape OVAL Size 14mm Flavor Imprint Code B;352 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-352-01 100 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved other		09/01/2006

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Nexgen Pharma		048488621	MANUFACTURE

Revised: 10/2009Breckenridge Pharmaceutical, Inc.

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• Folplex Side Effects (in more detail)
• Folplex Dosage
• Folplex Use in Pregnancy & Breastfeeding
• Folplex Drug Interactions
• Folplex Support Group
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