Folivane-PRx DHA NF

Generic Name: ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium
Dosage Form: capsule

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.

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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:13811-544-30 30 CAPSULE (CAPSULE) in 1 BOTTLE
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: 09/2011
 
TRIGEN Laboratories, Inc.
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