Folplex

Generic Name: folic acid, cholecalciferol and pyridoxine hydrochloride
Dosage Form: tablet, coated

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.

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.

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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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:51991-352-01 100 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
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: 10/2009
 
Breckenridge Pharmaceutical, Inc.
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