Tuesday, October 18, 2016

Nexa Select





Dosage Form: capsule, gelatin coated
Nexa™ Select capsules

Rx only



Rx Prenatal Vitamin with Plant-Based DHA


  • 1.25 mg Folic Acid and 325 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 plant-based DHA. Nexa™ Select capsules are available as opaque brown, oblong capsules imprinted "0244" and are available in 30-count bottles (NDC 0245-0244-30).


Each softgel capsule contains:




















Vitamin C (ascorbic acid, USP)28 mg
Vitamin E (d-alpha tocopherol, USP)30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)25 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
DHA (docosahexaenoic acid, contained in the oil derived from microalgae)325 mg
Docusate Sodium, USP55 mg

Inactive Ingredients: Ethyl vanillin, FD&C Yellow #6, FD&C Red #40, FD&C Blue #1, gelatin, glycerin, lecithin, soybean oil, titanium dioxide, yellow beeswax, water and 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 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.



Nexa Select Dosage and Administration


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



How is Nexa Select Supplied


Nexa™ Select capsules are available as opaque brown, oblong capsules imprinted "0224" and are available in 30-count bottles (NDC 0245-0244-30).



KEEP THIS AND ALL DRUGS OUT OF 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 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

MADE IN CANADA


1-800-654-2299    www.upsher-smith.com

US Patents 5,407,957; 5,492,938. Other US Patents Pending.


Revised 1110



PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label


NDC 0245-0244-30

Rx ONLY


Daily-Capsule

Nexa™ Select


Rx Prenatal Vitamin

with Plant-Based DHA


ONCE-DAILY

DHA

PLANT-BASED


ESSENTIAL VITAMINS,

MINERALS AND DHA

WITH A GENTLE

STOOL SOFTENER


30 SOFTGEL CAPSULES


UPSHER-SMITH










Nexa Select 
ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, pyridoxine hydrochloride, folic acid, alpha-tocopherol, doconexent, and docusate sodium  capsule, gelatin coated










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0245-0244
Route of AdministrationORALDEA Schedule    
































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (Ascorbic Acid)Ascorbic Acid28 mg
tribasic calcium phosphate (calcium cation)tribasic calcium phosphate160 mg
ferrous fumarate (iron)ferrous fumarate29 mg
cholecalciferol (cholecalciferol)cholecalciferol800 [iU]
pyridoxine hydrochloride (pyridoxine)pyridoxine hydrochloride25 mg
folic acid (folic acid)folic acid1.25 mg
alpha-tocopherol (alpha-tocopherol)alpha-tocopherol30 [iU]
doconexent (doconexent)doconexent325 mg
docusate sodium (docusate)docusate sodium55 mg




































Inactive Ingredients
Ingredient NameStrength
ethyl vanillin 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
gelatin 
glycerin 
lecithin, soybean 
soybean oil 
titanium dioxide 
yellow wax 
water 
ammonia 
isopropyl alcohol 
butyl alcohol 
propylene glycol 
dimethicone 


















Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize24mm
FlavorImprint Code0244
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
10245-0244-665 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
11 CAPSULE In 1 BLISTER PACKThis package is contained within the CARTON (0245-0244-66)
20245-0244-3030 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/25/2011


Labeler - Upsher-Smith Laboratories, Inc. (047251004)









Establishment
NameAddressID/FEIOperations
Upsher-Smith Laboratories, Inc.047251004ANALYSIS









Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727ANALYSIS, MANUFACTURE
Revised: 01/2011Upsher-Smith Laboratories, Inc.

More Nexa Select resources


  • Nexa Select Use in Pregnancy & Breastfeeding
  • Drug Images
  • Nexa Select Drug Interactions
  • Nexa Select Support Group
  • 21 Reviews for Nexa Select - Add your own review/rating


Compare Nexa Select with other medications


  • Vitamin/Mineral Supplementation during Pregnancy/Lactation

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