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Nexa Plus

Upsher-Smith Laboratories, Inc.

Nexa Plus Capsules


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx only

Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil

  • 1.25 mg Folic Acid and 350 mg DHA (key omega-3 fatty acid)
  • Essential vitamins and minerals
  • Gentle stool softener

NEXA PLUS 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).

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 mg158 mg calcium from calcium carbonate, USP and 2 mg calcium from docusate calcium, USP
Iron (ferrous fumarate, USP) 29 mg
Algal oil blend (derived from Crypthecodinium cohnii) 660 mgProviding 350 mg DHA (docosahexaenoic acid)
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.

NEXA PLUS 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.

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.

NEXA PLUS 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 PLUS 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

Nexa Plus

Nexa Plus

Ascorbic Acid, Cholecalciferol, .Alpha.-Tocopherol, Pyridoxine, Folic Acid, Biotin, Calcium, Iron, Docusate Calcium, and Crypthecodinium cohnii dha oil CAPSULE

Product Information

Product Type Human prescription drug label 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 28 mg
CHOLECALCIFEROL CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL 30 [iU]
PYRIDOXINE 25 mg
FOLIC ACID FOLIC ACID 1.25 mg
BIOTIN 250 ug
CALCIUM CALCIUM 160 mg
IRON IRON 29 mg
Docusate Calcium DOCUSATE 55 mg
Crypthecodinium cohnii dha oil CRYPTHECODINIUM COHNII 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 Size Imprint Code Shape
BROWN (opaque brown) 24 mm 374 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0245-0374-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-08-01


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