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Nexa Select

Upsher-Smith Laboratories, Inc.

Nexa Select capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only

Rx Prenatal Vitamin with Crypthecodinium cohnii algal oil providing plant-based DHA

  • 1.25 mg Folic Acid and 337.5 mg DHA (key omega-3 fatty acid)
  • Essential vitamins and minerals
  • Gentle stool softener

NEXA SELECT DESCRIPTION

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

Each softgel capsule contains:

Vitamin C (ascorbic acid, USP) 28 mg
Vitamin E (d-alpha tocopherol, USP) 30 IU
Vitamin B6 (pyridoxine hydrochloride, USP) 28 mg
Folic Acid, USP 1.25 mg
Calcium (tribasic calcium phosphate, NF) 160 mg
Iron (ferrous fumarate, USP) 29 mg
Vitamin D3 (cholecalciferol, USP) 800 IU
Algal oil blend (derived from Crypthecodinium cohnii) 750 mgProviding 337.5 mg DHA (docosahexaenoic acid)
Docusate Sodium, USP 55 mg

Inactive Ingredients: Ascorbyl palmitate, ethyl vanillin, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerine, lecithin, medium chain triglycerides, sodium benzoate, soybean oil, sunflower oil, titanium dioxide, tocopherols, 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® Select capsules are indicated to provide vitamin/mineral and C. cohnii algal oil providing plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Nexa® Select may be useful in improving the nutritional status of women prior to conception.

NEXA SELECT CONTRAINDICATIONS

Nexa® Select 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.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE 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.

NEXA SELECT 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.

NEXA SELECT DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

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

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 1-855-899-9180.

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

Distributed by
UPSHER-SMITH LABORATORIES, INC.
Maple Grove, MN 55369
MADE IN CANADA

1-800-654-2299 www.upsher-smith.com
US Patents 5,407,957; 5,492,938. Other US Patents Pending.

Revised 0812

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 0245-0245-30
Rx ONLY

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

ONCE-DAILY
DHA
FROM ALGAL OIL

ESSENTIAL VITAMINS,
MINERALS AND DHA
WITH A GENTLE
STOOL SOFTENER

30 SOFTGEL CAPSULES
UPSHER-SMITH

Nexa Select

Nexa Select

Ascorbic Acid, .Alpha.-Tocopherol, Pyridoxine, Folic Acid, Calcium, Iron, Cholecalciferol, CRYPTHECODINIUM COHNII DHA OIL, and Docusate Sodium CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0245-0245
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 28 mg
.ALPHA.-TOCOPHEROL 30 [iU]
PYRIDOXINE 28 mg
FOLIC ACID FOLIC ACID 1.25 mg
CALCIUM CALCIUM 160 mg
IRON IRON 29 mg
CHOLECALCIFEROL CHOLECALCIFEROL 800 [iU]
Crypthecodinium cohnii dha oil CRYPTHECODINIUM COHNII DHA OIL 750 mg
DOCUSATE SODIUM DOCUSATE 55 mg

Inactive Ingredients

Ingredient Name Strength
ASCORBYL PALMITATE
ETHYL VANILLIN
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
SODIUM BENZOATE
SOYBEAN OIL
SUNFLOWER OIL
titanium dioxide
Tocopherol
YELLOW WAX
AMMONIA
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
propylene glycol
SHELLAC
DIMETHICONE
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
BROWN 24 mm 0245 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0245-0245-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-12-17


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