Folivane -PRx DHA description, usages, side effects, indications, overdosage, supplying and lots more!

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Folivane -PRx DHA

TRIGEN Laboratories, Inc.

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


FULL PRESCRIBING INFORMATION: CONTENTS*




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.

Supplement Facts
Servings per Bottle: 30
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains:
%DV for Pregnant and Lactating Women
Vitamin C (ascorbic acid, USP) 25 mg 42%
Calcium (tribasic calcium phosphate, NF) 160 mg 12%
Iron (ferrous fumarate, USP) 30 mg 167%
Vitamin D3 (cholecalciferol, USP) 170 IU 43%
Vitamin E(d-alpha tocopherol, USP) 30 IU 100%
Vitamin B6 (pyridoxine HCl, USP) 25 mg 1000%
Folic Acid, USP 1.24 mg 155%
DHA (docosahexaenoic acid)* 265 mg
Docusate Sodium, USP 55 mg 4%
* From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil.

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.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of 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.

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.

Rx 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
Rx Only

Folivane-PRx DHA
NF

Rx PRENATAL VITAMIN

30 CAPSULES

TRIGEN
LABORATORIES

Folivane -PRx DHA

Folivane -PRx DHA

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

Product Information

Product Type Dietary supplement 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 25 mg
TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION 160 mg
FERROUS FUMARATE FERROUS CATION 30 mg
CHOLECALCIFEROL CHOLECALCIFEROL 170 [iU]
ALPHA-TOCOPHEROL 30 [iU]
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 25 mg
FOLIC ACID FOLIC ACID 1.24 mg
DOCONEXENT DOCONEXENT 265 mg
DOCUSATE SODIUM DOCUSATE 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 Size Imprint Code Shape
RED (maroon) 25 mm T544 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-544-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-01-01


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