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Folplex Prescribing Information

Package insert / product label
Generic name: folic acid, vitamin B12 and pyridoxine hydrochloride
Dosage form: tablet, coated
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

The Folplex brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

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 for Folplex

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/Side Effects

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

Warnings

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 Dosage and Administration

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

How is Folplex 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

Principal Display Panel - 100 Tablets Bottle
FOLPLEX
folic acid, vitamin B12 and pyridoxine hydrochloride tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51991-352
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid2.2 mg
vitamin B12 (UNII: 1C6V77QF41) (vitamin B12 - UNII:1C6V77QF41) vitamin B121 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine25 mg
Inactive Ingredients
Ingredient NameStrength
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Croscarmellose Sodium (UNII: M28OL1HH48)
Crospovidone (UNII: 68401960MK)
Magnesium Stearate (UNII: 70097M6I30)
Hypromellose (UNII: 3NXW29V3WO)
Titanium Dioxide (UNII: 15FIX9V2JP)
Polydextrose (UNII: VH2XOU12IE)
Triacetin (UNII: XHX3C3X673)
Polyethylene Glycol (UNII: 3WJQ0SDW1A)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Product Characteristics
ColorPINKScore2 pieces
ShapeOVALSize14mm
FlavorImprint CodeB;352
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51991-352-01100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved other09/01/2006
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma048488621MANUFACTURE

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