NEXA PLUS - ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, biotin, calcium, iron, docusate calcium and schizochytrium dha oil capsule 
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

Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil

DESCRIPTION

Nexa® Plus Capsules are a prescription prenatal / postnatal multivitamin / mineral softgel capsule with plant-based DHA. Nexa® Plus Capsules are available as opaque brown, oblong capsules imprinted "0374" and are available in 30-count bottles (NDC 0245-0374-30).

*
158 mg calcium from calcium carbonate, USP and 2 mg calcium from docusate calcium, USP
Providing 350 mg DHA (docosahexaenoic acid)
Each softgel capsule contains:
Vitamin C (ascorbic acid, USP) 28 mg
Vitamin D3 (cholecalciferol, USP) 800 IU
Vitamin E (d-alpha tocopherol, USP) 30 IU
Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg
Folic Acid, USP 1.25 mg
Biotin 250 mcg
Calcium 160 mg*
Iron (ferrous fumarate, USP) 29 mg
Algal oil blend (derived from Crypthecodinium cohnii) 660 mg
Docusate Calcium, USP 55 mg

Other Ingredients:

Ascorbyl palmitate, corn oil, ethyl vanillin, FD&C Yellow #6, FD&C Red #40, FD&C Blue #1, gelatin, glycerin, lecithin, soybean oil, sunflower oil, titanium dioxide, water, yellow beeswax, white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide).

Contains: Soy

INDICATIONS

Nexa® Plus Capsules are indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Nexa® Plus may be useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

Nexa® Plus Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTION

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.

ADVERSE REACTIONS

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

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

HOW SUPPLIED

Nexa® Plus Capsules are available as opaque brown, oblong capsules imprinted "0374" and are available in 30-count bottles (NDC 0245-0374-30).

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

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Upsher-Smith Laboratories, Inc. at 1-888-650-3789.

Store at 20° – 25°C (68° – 77° F). [See USP Controlled Room Temperature.]

Distributed by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447

106408-01

Revised 0312

1-800-654-2299  www.upsher-smith.com
© 2012 Upsher-Smith Laboratories, Inc.
All rights reserved.
US Patents 5,407,957; 5,492,938

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 0245-0374-30
Rx ONLY

Daily-Capsule
Nexa®Plus
Rx Prenatal Vitamin
with Plant-Based DHA

ONCE-DAILY
DHA
FROM ALGAL OIL

ESSENTIAL VITAMINS
AND MINERALS INCLUDING
BIOTIN, PLUS DHA AND A
GENTLE STOOL SOFTENER

30 SOFTGEL CAPSULES

UPSHER-SMITH

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NEXA PLUS 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, biotin, calcium, iron, docusate calcium, and schizochytrium dha oil capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0245-0374
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 28 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 800 [iU]
.Alpha.-Tocopherol (.Alpha.-Tocopherol) .Alpha.-Tocopherol 30 [iU]
Pyridoxine (Pyridoxine) Pyridoxine 25 mg
Folic Acid (Folic Acid) Folic Acid 1.25 mg
Biotin (Biotin) Biotin 250 ug
Calcium (Calcium) Calcium 160 mg
Iron (Iron) Iron 29 mg
Docusate Calcium (Docusate) Docusate Calcium 55 mg
Schizochytrium DHA Oil (Schizochytrium DHA Oil) Schizochytrium DHA Oil 660 mg
Inactive Ingredients
Ingredient Name Strength
ascorbyl palmitate  
corn oil  
ethyl vanillin  
FD&C Yellow No. 6  
FD&C Red No. 40  
FD&C Blue No. 1  
gelatin  
glycerin  
egg phospholipids  
soybean oil  
sunflower oil  
titanium dioxide  
water  
yellow wax  
ammonia  
isopropyl alcohol  
butyl alcohol  
propylene glycol  
soy protein  
shellac  
Product Characteristics
Color BROWN (opaque brown) Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code 374
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0245-0374-30 30 CAPSULE in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2012

Labeler - Upsher-Smith Laboratories, Inc. (047251004)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, Inc. 047251004 RELABEL, REPACK
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions 051762268 MANUFACTURE, ANALYSIS

Revised: 07/2012 Upsher-Smith Laboratories, Inc.