NEXA SELECT  RX PRENATAL VITAMIN WITH PLANT-BASED DHA- ascorbic acid, .alpha.-tocopherol, pyridoxine, folic acid, calcium, iron, cholecalciferol, crypthecodinium cohnii dha oil, and docusate sodium 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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Nexa® Select capsules

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

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:

*
Providing 337.5 mg DHA (docosahexaenoic acid)
Vitamin C (ascorbic acid, USP)28 mg
Vitamin E (d-alpha tocopherol, USP)30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)28 mg
Folic Acid, USP1.25 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 mg*
Docusate Sodium, USP55 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.

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.

WARNING

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.

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® 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

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
NEXA SELECT   RX PRENATAL VITAMIN WITH PLANT-BASED DHA
ascorbic acid, .alpha.-tocopherol, pyridoxine, folic acid, calcium, iron, cholecalciferol, crypthecodinium cohnii dha oil, and docusate sodium capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0245-0245
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid28 mg
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol30 [iU]
Pyridoxine (UNII: KV2JZ1BI6Z) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine28 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1.25 mg
Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium160 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol800 [iU]
CRYPTHECODINIUM COHNII DHA OIL (UNII: 8ZJ335A17J) (CRYPTHECODINIUM COHNII DHA OIL - UNII:8ZJ335A17J) CRYPTHECODINIUM COHNII DHA OIL750 mg
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium55 mg
Inactive Ingredients
Ingredient NameStrength
Ascorbyl palmitate (UNII: QN83US2B0N)  
ethyl vanillin (UNII: YC9ST449YJ)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
FD&C Red NO. 40 (UNII: WZB9127XOA)  
FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
gelatin, unspecified (UNII: 2G86QN327L)  
glycerin (UNII: PDC6A3C0OX)  
lecithin, soybean (UNII: 1DI56QDM62)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
sodium benzoate (UNII: OJ245FE5EU)  
soybean oil (UNII: 241ATL177A)  
sunflower oil (UNII: 3W1JG795YI)  
titanium dioxide (UNII: 15FIX9V2JP)  
tocopherol (UNII: R0ZB2556P8)  
yellow wax (UNII: 2ZA36H0S2V)  
ammonia (UNII: 5138Q19F1X)  
isopropyl alcohol (UNII: ND2M416302)  
butyl alcohol (UNII: 8PJ61P6TS3)  
propylene glycol (UNII: 6DC9Q167V3)  
shellac (UNII: 46N107B71O)  
dimethicone (UNII: 92RU3N3Y1O)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize24mm
FlavorImprint Code 0245
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0245-0245-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/17/201204/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER12/17/201204/30/2014
Labeler - Upsher-Smith Laboratories, Inc. (047251004)

Revised: 10/2017
 
Upsher-Smith Laboratories, Inc.