B-Nexa Tablets

Dosage Form: tablet
B-NEXA® TABLETS

Rx only

B-Nexa Tablets Description

B-Nexa® Tablets are a prescription prenatal vitamin that provide B-vitamin nutrition and are formulated with vitamin B6 and ginger to help calm nausea and vomiting of pregnancy (NVP). B-Nexa® Tablets contain 100 mg ginger root powder extract that, when standardized to gingerols, is equivalent to 500 mg ginger root powder. Each caplet shaped tablet is engraved "US" on one side and "214" on the other with a pink film coat.

Each pink tablet contains:

Vitamin B6 (pyridoxine hydrochloride, USP)	40 mg
Folic Acid, USP	1.2 mg
Calcium (as dicalcium phosphate and tricalcium phosphate)	124.1 mg
Ginger (zingiber officinale) root powder extract	100 mg

Other Ingredients: microcrystalline cellulose, maltodextrin, talc, corn starch, croscarmellose sodium, stearic acid, hypromellose, hydroxypropyl cellulose, magnesium stearate, silicon dioxide, titanium dioxide, iron oxide red, iron oxide yellow, iron oxide black.

INDICATIONS

B-Nexa® Tablets are indicated to provide B-vitamin supplementation, with ginger to help calm pregnancy related nausea and vomiting (morning sickness), and may be used in conjunction with a physician prescribed prenatal regimen.

Contraindications

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

Precautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.

Adverse Reactions

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

B-Nexa Tablets Dosage and Administration

One or two tablets daily, in divided doses, or as directed by a physician.

How is B-Nexa Tablets Supplied

Bottles of 60 tablets (NDC 0245-0214-60).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

DO NOT CHEW

Store at controlled room temperature, 15-30°C (59-86°F). Protect from light and moisture.

Distributed by:

UPSHER-SMITH LABORATORIES, INC.

6701 Evenstad Drive

Maple Grove, MN 55369

1-800-654-2299 www.upsher-smith.com

104472-06

Revised 0911

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC 0245-0214-60

Rx ONLY

NEW!

TABLETS

B-Nexa™

Rx PRENATAL VITAMIN WITH

B VITAMINS AND GINGER

UNIQUELY FORMULATED WITH

VITAMIN B6 AND GINGER TO HELP

CALM NAUSEA AND VOMITING

OF PREGNANCY (NVP)

60 TABLETS

B-NEXA  pyridoxine, folic acid, calcium, and ginger  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0245-0214 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyridoxine (Pyridoxine) Pyridoxine 40 mg Folic Acid (Folic Acid) Folic Acid 1.2 mg Calcium (Calcium) Calcium 124.1 mg Ginger (Ginger) Ginger 100 mg

Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline   Maltodextrin   Talc   Starch, Corn   Croscarmellose Sodium   Stearic Acid   Hypromelloses   Silicon Dioxide   Titanium Dioxide   Hydroxypropyl Cellulose   Magnesium Stearate   Ferrosoferric Oxide   Ferric Oxide Yellow   Ferric Oxide Red

Product Characteristics Color PINK Score no score Shape OVAL Size 24mm Flavor Imprint Code US;214 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0245-0214-60 60 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		12/08/2011

Labeler - Upsher-Smith Laboratories, Inc. (047251004)

Establishment
Name	Address	ID/FEI	Operations
Upsher-Smith Laboratories, Inc.		047251004	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Accucaps Industries Limited		248441727	ANALYSIS, MANUFACTURE

Revised: 12/2011Upsher-Smith Laboratories, Inc.