B-Nexa

Upsher-Smith Laboratories, Inc.

B-NEXA TABLETS

FULL PRESCRIBING INFORMATION: CONTENTS*

• B-NEXA DESCRIPTION
  • Each pink tablet contains
  • Other Ingredients
• INDICATIONS
• B-NEXA CONTRAINDICATIONS
• PRECAUTIONS
• B-NEXA ADVERSE REACTIONS
• B-NEXA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

Rx only

B-NEXA 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

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.

B-NEXA 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.

B-NEXA ADVERSE REACTIONS

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

B-NEXA 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