PreNexa

Generic Name: ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, .alpha.-tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium
Dosage Form: capsule, gelatin coated

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.

PreNexa® Capsules

Rx only

Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil

  • 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid)
  • Essential vitamins and minerals
  • Gentle stool softener

PreNexa Description

PreNexa® Capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with plant-based DHA. Each softgel capsule is brown in color, opaque, and imprinted with "PreNexa".

Each softgel capsule contains:
*
Providing 300 mg DHA (docosahexaenoic acid)
Vitamin C (ascorbic acid, USP) 28 mg
Calcium (tribasic calcium phosphate, NF) 160 mg
Iron (ferrous fumarate, USP) 27 mg
Vitamin D3 (cholecalciferol, USP) 400 IU
Vitamin E (d-alpha tocopherol, USP) 30 IU
Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg
Folic Acid, USP 1.25 mg
Algal oil (derived from Crypthecodinium cohnii) 750 mg*
Docusate Sodium, USP 55 mg

Inactive Ingredients: Ethyl vanillin, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, palm kernel oil, sodium benzoate, soybean oil, sunflower 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

PreNexa® 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. PreNexa® may be useful in improving the nutritional status of women prior to conception.

Contraindications

PreNexa® 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.

PreNexa Dosage and Administration

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

How is PreNexa Supplied

Bottles of 30 softgel capsules (NDC 0245-0178-30).

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
MADE IN CANADA

1-800-654-2299 www.upsher-smith.com
US Patents 5,407,957; 5,492,938. Other US Patents Pending.
© 2012 Upsher-Smith Laboratories, Inc.
104300-03

Revised 0811

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 0245-0178-30
Rx ONLY

DAILY-CAPSULE
PreNexa®

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

PreNexa 
ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0245-0178
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 28 mg
Tribasic Calcium Phosphate (Calcium Cation) Calcium Cation 160 mg
Ferrous Fumarate (Ferrous Cation) Ferrous Cation 27 mg
Cholecalciferol (cholecalciferol) Cholecalciferol 400 [iU]
.Alpha.-Tocopherol (.alpha.-tocopherol) .Alpha.-Tocopherol 30 [iU]
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
folic acid (folic acid) folic acid 1.25 mg
doconexent (doconexent) doconexent 300 mg
docusate sodium (docusate) docusate sodium 55 mg
Inactive Ingredients
Ingredient Name Strength
ethyl vanillin  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
gelatin  
glycerin  
lecithin, soybean  
palm kernel oil  
sodium benzoate  
soybean oil  
sunflower oil  
titanium dioxide  
yellow wax  
water  
ammonia  
isopropyl alcohol  
butyl alcohol  
propylene glycol  
DIMETHICONE  
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 24mm
Flavor Imprint Code PreNexa
Contains         
Packaging
# Item Code Package Description
1 NDC:0245-0178-66 5 BLISTER PACK in 1 CARTON
1 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK
2 NDC:0245-0178-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/25/2010
Labeler - Upsher-Smith Laboratories, Inc. (047251004)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories, Inc. 047251004 ANALYSIS(0245-0178)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 MANUFACTURE(0245-0178), ANALYSIS(0245-0178)
Revised: 02/2013
 
Upsher-Smith Laboratories, Inc.
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