Folivane -PRx DHA

TRIGEN Laboratories, Inc.

Folivane™- PRx DHA NF Rx PRENATAL VITAMIN with Fish Oil-Based DHARx only

FULL PRESCRIBING INFORMATION: CONTENTS*

• FOLIVANE -PRX DHA DESCRIPTION
  • Inactive Ingredients:
• INDICATIONS
• FOLIVANE -PRX DHA CONTRAINDICATIONS
• THIS PRODUCT CONTAINS SOYBEAN OIL AND FISH OIL.
• WARNING
• PRECAUTION
• FOLIVANE -PRX DHA ADVERSE REACTIONS
• CAUTION
• FOLIVANE -PRX DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

FOLIVANE -PRX DHA DESCRIPTION

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

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.

FOLIVANE -PRX DHA 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.

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.

FOLIVANE -PRX DHA ADVERSE REACTIONS

Allergic sensitization has been reported with 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 DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, One (1) softgel capsule daily or as directed by a physician.

HOW SUPPLIED

Folivane™-PRx DHA NF is supplied in bottles of 30 softgel capsules.

Product Code: 13811-544-30

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF THE REACH OF CHILDREN.

R_x Only.

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 05/13

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

13811-544-30
R_x Only

Folivane™-PRx DHA
NF

Rx PRENATAL VITAMIN

30 CAPSULES

TRIGEN
LABORATORIES