PreNexa

ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium

Dosage Form: capsule, gelatin coated
PreNexa® Capsules

Rx only

Rx Prenatal Vitamin with plant-Based DHA

• 1.2 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:

Vitamin C (ascorbic acid, USP)	28 mg
Calcium (tribasic calcium phosphate, NF)	160 mg
Iron (ferrous fumarate, USP)	26 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	1.2 mg
DHA (docosahexaenoic acid, contained in the oil derived from microalgae)	300 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 0245-0177-30).

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

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; 6,977,167. Other US Patents Pending.

104067-01

Revised 0110

PRINCIPAL DISPLAY PANEL - Capsule Label

Newly

Formulated

NDC 0245-0177-30

Rx ONLY

DAILY-CAPSULE

PreNexa®

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

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 NDC Product Code (Source) 0245-0177 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) tribasic calcium phosphate 160 mg ferrous fumarate (iron) ferrous fumarate 26 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 1.2 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   wax, yellow   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 # NDC Package Description Multilevel Packaging 1 0245-0177-66 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 1 CAPSULE In 1 BLISTER PACK This package is contained within the CARTON (0245-0177-66) 2 0245-0177-30 30 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/27/2010

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

Establishment
Name	Address	ID/FEI	Operations
Upsher-Smith Laboratories, Inc.		047251004	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Accucaps Industries Limited		248441727	ANALYSIS, MANUFACTURE

Revised: 11/2009Upsher-Smith Laboratories, Inc.

More PreNexa resources

• PreNexa Side Effects (in more detail)
• PreNexa Use in Pregnancy & Breastfeeding
• PreNexa Drug Interactions
• PreNexa Support Group
• 2 Reviews for PreNexa - Add your own review/rating

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