Folivane-PRx DHA NF

Dosage Form: capsule
Folivane™-PRx DHA NF

Rx Prenatal Vitamin with Fish Oil-Based DHA

Rx Only.

Folivane-PRx DHA NF Description

Folivane™-PRx DHA NF capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with "T544" in white ink.

* From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil.
Each softgel capsule contains:
Vitamin C (ascorbic acid, USP)	25 mg
Calcium (tribasic calcium phosphate, NF)	160 mg
Iron (ferrous fumarate, USP)	30 mg
Vitamin D3 (cholecalciferol, USP)	170 IU
Vitamin E (d-alpha tocopherol, USP)	30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)	25 mg
Folic Acid, USP	1.24 mg
DHA (Docosahexaenoic Acid)*	265 mg
Docusate Sodium, USP	55 mg

Inactive Ingredients

Gelatin, Glycerin, Soybean Oil, Purified Water, Lecithin, Natural Creamy Orange Flavor, Yellow Beeswax, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1.

INDICATIONS

Folivane™-PRx DHA NF capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Folivane™-PRx DHA NF may be useful in improving the nutritional status of women prior to conception.

Contraindications

Folivane™-PRx DHA NF capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. 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.

This product contains soybean oil and fish oil.

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

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.

Folivane-PRx DHA NF Dosage and Administration

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

How is Folivane-PRx DHA NF Supplied

Bottles of 30 softgel capsules NDC 13811-544-30.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F [see USP controlled room temperature].

Rx Only.

Manufactured for:

TRIGEN Laboratories, Inc., Sayreville, NJ 08872

www.trigenlab.com

Rev. 08/11

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-544-30

Rx Only

Folivane™-PRx DHA

NF

Rx PRENATAL VITAMIN

30 CAPSULES

TRIGEN

LABORATORIES

FOLIVANE-PRX DHA  ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-544 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 25 mg Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 160 mg Iron (Iron) Iron 30 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 170 [iU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1.24 mg Doconexent (Doconexent) Doconexent 265 mg Docusate Sodium (Docusate) Docusate Sodium 55 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Glycerin   Soybean Oil   Water   Yellow Wax   FD&C Red No. 40   Titanium Dioxide   Ethyl Vanillin   FD&C Yellow No. 6   FD&C Blue No. 1

Product Characteristics Color RED (maroon) Score no score Shape CAPSULE (oblong) Size 25mm Flavor ORANGE (Creamy Orange) Imprint Code T544 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-544-30 30 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/2010

Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 09/2011TRIGEN Laboratories, Inc.