Nexa® Plus Capsules

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.

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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, USP1.25 mg
Biotin250 mcg
Calcium160 mg*
Iron (ferrous fumarate, USP)29 mg
Algal oil blend (derived from Crypthecodinium cohnii)660 mg
Docusate Calcium, USP55 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0245-0374
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid28 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol800 [iU]
.Alpha.-Tocopherol (.Alpha.-Tocopherol) .Alpha.-Tocopherol30 [iU]
Pyridoxine (Pyridoxine) Pyridoxine25 mg
Folic Acid (Folic Acid) Folic Acid1.25 mg
Biotin (Biotin) Biotin250 ug
Calcium (Calcium) Calcium160 mg
Iron (Iron) Iron29 mg
Docusate Calcium (Docusate) Docusate Calcium55 mg
Schizochytrium DHA Oil (Schizochytrium DHA Oil) Schizochytrium DHA Oil660 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBROWN (opaque brown) Score no score
ShapeCAPSULESize24mm
FlavorImprint Code 374
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0245-0374-3030 CAPSULE in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER08/01/2012

Labeler - Upsher-Smith Laboratories, Inc. (047251004)
Establishment
NameAddressID/FEIOperations
Upsher-Smith Laboratories, Inc.047251004RELABEL, REPACK
Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions051762268MANUFACTURE, ANALYSIS

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