VemaVite-PRx 2

Generic Name: prenatal vitamin with fish-based DHA
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.

VemaVite™-PRx 2 Rx Prenatal Vitamin
with Fish-Based DHA

Rx Only

  • 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid)
  • Essential vitamins and minerals
  • Gentle stool softener

VemaVite-PRx 2 Description

VemaVite™-PRx 2 is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is an oblong, maroon softgel capsule imprinted with "T598" in white ink.

Each softgel capsule contains:
*
Derived from at least 338.1 mg omega-3s from at least 476.1 mg purified fish oil.
Vitamin C (ascorbic acid, USP) 28 mg  
Calcium (tribasic calcium phosphate, NF) 160 mg  
Iron (ferrous fumarate, USP) 27 mg  
Vitamin D3 (cholecalciferol, USP) 400 IU  
Vitamin E (d-alpha tocopherol, USP) 30 IU  
Vitamin B6 (pyridoxine hydrochloride, USP) 25 mg  
Folic Acid, USP 1.25 mg  
DHA (docosahexaenoic acid, contained in the oil derived from fish) 300 mg*
Docusate Sodium, USP 55 mg  

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

INDICATIONS

VemaVite™-PRx 2 softgel 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. VemaVite™-PRx 2 may be useful in improving the nutritional status of women prior to conception.

Contraindications

VemaVite™-PRx 2 is 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 FISH OIL AND SOY.

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.

VemaVite-PRx 2 Dosage and Administration

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

How is VemaVite-PRx 2 Supplied

Bottles of 30 softgel capsules.

NDC 13811-598-30

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Store at Controlled Room Temperature 20°-25°C (68°-77°F). [See USP].

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

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Rx Only

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

MADE IN CANADA

Rev. 10/10

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-598-30
Rx Only

VemaVite™-PRx 2
Softgel Capsule

30 CAPSULES

TRIGEN
LABORATORIES

VemaVite-PRx 2   WITH FISH-BASED DHA
ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-598
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 28 mg
Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 160 mg
Ferrous Fumarate (Iron) Ferrous Fumarate 27 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 30 [iU]
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 1.25 mg
Doconexent (Doconexent) Doconexent 300 mg
Docusate Sodium (Docusate) Docusate Sodium 55 mg
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 1  
FD&C Red No. 40  
FD&C Yellow No. 6  
Gelatin  
Glycerin  
Water  
Soybean Oil  
Titanium Dioxide  
Ethyl Vanillin  
Yellow Wax  
Product Characteristics
Color RED (maroon) Score no score
Shape CAPSULE (oblong) Size 25mm
Flavor ORANGE (Creamy Orange) Imprint Code T598
Contains         
Packaging
# Item Code Package Description
1 NDC:13811-598-30 30 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 10/05/2011
Labeler - TRIGEN Laboratories, Inc. (830479668)
Revised: 09/2011
 
TRIGEN Laboratories, Inc.
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