PRENEXA PREMIER - ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium capsule, gelatin coated 
Upsher-Smith Laboratories, Inc.

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PreNexa® premier capsules

Rx only

Rx Prenatal Vitamin with Plant-Based DHA

DESCRIPTION

PreNexa® premier capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with plant-based DHA. PreNexa® premier capsules are available as opaque brown, oblong capsules imprinted "0179" and are available in 30-count bottles (NDC 0245-0179-30).

Each softgel capsule contains:

Vitamin C (ascorbic acid, USP)28 mg
Calcium (tribasic calcium phosphate, NF)160 mg
Iron (ferrous fumarate, USP)27 mg
Vitamin D3 (cholecalciferol, USP)800 IU
Vitamin E (d-alpha tocopherol, USP)30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)25 mg
Folic Acid, USP1.25 mg
DHA (docosahexaenoic acid, contained in the oil derived from microalgae)310 mg
Docusate Sodium, USP55 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® premier 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® premier may be useful in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

PreNexa® premier 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

PreNexa® premier capsules are available as opaque brown, oblong capsules imprinted "0179" and are available in 30-count bottles (NDC 0245-0179-30).

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; 6,410,281; 7,163,811. Other US Patents Pending.

PreNexa® premier capsules

Revised 0710

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 0245-0179-30
Rx ONLY

DAILY-CAPSULE
PreNexa®
premier
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

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

PRENEXA  PREMIER
ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium   capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0245-0179
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 fumarate27 mg
cholecalciferol (cholecalciferol) cholecalciferol800 [iU]
alpha-tocopherol (alpha-tocopherol) alpha-tocopherol30 [iU]
pyridoxine hydrochloride (pyridoxine) pyridoxine hydrochloride25 mg
folic acid (folic acid) folic acid1.25 mg
doconexent (doconexent) doconexent310 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 
palm kernel oil 
sodium benzoate 
soybean oil 
sunflower oil 
titanium dioxide 
yellow wax 
water 
ammonia 
isopropyl alcohol 
butyl alcohol 
propylene glycol 
DIMETHICONE 
Product Characteristics
ColorBROWNScore no score
ShapeCAPSULESize24mm
FlavorImprint Code 0179
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
10245-0179-665 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
11 CAPSULE In 1 BLISTER PACKThis package is contained within the CARTON (0245-0179-66)
20245-0179-3030 CAPSULE In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/18/201001/28/2011

Labeler - Upsher-Smith Laboratories, Inc. (047251004)
Establishment
NameAddressID/FEIOperations
Upsher-Smith Laboratories, Inc.047251004ANALYSIS
Establishment
NameAddressID/FEIOperations
Accucaps Industries Limited248441727ANALYSIS, MANUFACTURE
Revised: 02/2011Upsher-Smith Laboratories, Inc.