B-Nexa

B-NEXA- pyridoxine, folic acid, calcium and ginger tablet
Upsher-Smith Laboratories, Inc.

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.

Rx only

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 “215″ on the other with a pink film coat.

Each pink tablet contains

Vitamin B6 (pyridoxine hydrochloride, USP) 42 mg
Folic Acid, USP 1.22 mg
Calcium (as dicalcium phosphate and
tricalcium phosphate) 124.23 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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Bottles of 60 tablets (NDC 0245-0215-60).

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

106199-01

Revised 0112

PRINCIPAL DISPLAY PANEL — 60 Tablet Bottle Label

NDC 0245-0215-60 Rx ONLY

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

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL -- 60 Tablet Bottle Label
(click image for full-size original)
B-NEXA
pyridoxine, folic acid, calcium, and ginger tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0215
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pyridoxine (Pyridoxine) Pyridoxine 42 mg
Folic Acid (Folic Acid) Folic Acid 1.22 mg
Calcium (Calcium) Calcium 124.23 mg
Ginger (Ginger) Ginger 100 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
Maltodextrin
Talc
Starch, Corn
Croscarmellose Sodium
Hydroxypropyl Cellulose
Magnesium Stearate
Silicon Dioxide
Titanium Dioxide
Ferric Oxide Red
Ferric Oxide Yellow
Ferrosoferric Oxide
Stearic Acid
Hypromelloses
Product Characteristics
Color PINK Score no score
Shape OVAL Size 24mm
Flavor Imprint Code US;215
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0245-0215-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/15/2012
Labeler — Upsher-Smith Laboratories, Inc. (047251004)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, Inc. 047251004 RELABEL (0245-0215), REPACK (0245-0215)
Establishment
Name Address ID/FEI Operations
L Perrigo Company 085893071 MANUFACTURE (0245-0215), ANALYSIS (0245-0215)

Revised: 08/2012 Upsher-Smith Laboratories, Inc.

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