| NDC | 69543-370-30 |
| Set ID | e554e0db-5f15-46d4-be02-dba3ba845063 |
| Category | DIETARY SUPPLEMENT |
| Packager | Virtus Pharmaceuticals |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- STATEMENT OF IDENTITY
- DESCRIPTION
-
DIRECTIONS FOR USE
Before, during, and/or after pregnancy regardless of lactation status, one softgel daily or as directed by a licensed healthcare practitioner.
Supplement Facts Serving Size: 1 Softgel Amount Per Serving % Daily Value for Pregnant & Lactating Women - *
- Daily Value not established
Vitamin C (as ascorbic acid) 100 mg 167% Vitamin D (Vitamin D3 as cholecalciferol) 400 IU 100% Vitamin E (as d-alpha tocopherol) 30 IU 100% Thiamin (as thiamine mononitrate) 3 mg 176% Riboflavin 3 mg 150% Vitamin B6 (as pyridoxine HCl) 20 mg 800% Folic Acid 1 mg 125% Vitamin B12 (as cyanocobalamin) 15 mcg 188% Iron (as ferrous fumarate) 28 mg 156% Magnesium (as magnesium oxide) 30 mg 7% Zinc (as zinc oxide) 20 mg 133% Copper (as cupric sulfate) 1 mg 50% Omega-3 Fatty Acids (DHA-EPA) 200 mg * Other Ingredients: Gelatin, Glycerin, Soybean Oil, Beeswax, Purified Water, Soy Lecithin, Natural Creamy Orange Flavor, Annatto Powder, Titanium Dioxide, and Ethyl Vanillin. Contains Fish Oil and Soy.
KEEP THIS OUT OF REACH OF CHILDREN
- CONTRAINDICATIONS
- WARNINGS
-
CAUTIONS
High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia, a condition that can cause nerve damage).
Concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin or other anticonvulsants.
Exercise caution with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.
The action of levodopa is antagonized by pyridoxine.
Products containing iron should not be used during dimercaprol therapy. Dimercaprol can bind to iron and cause kidney damage.
Avoid administering omega-3 fatty acids to patients with inherited or acquired predisposition toward bleeding, including patients taking anticoagulants. Exercise caution with these patients to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
- SIDE EFFECTS
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DRUG INTERACTIONS
Folic Acid
Concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur.
Folinic acid may enhance the toxicity of fluorouracil.
High levels of folic acid may result in decreased serum levels of pyrimethamine.
Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the hematopoietic response to folate.
Antiepileptic drugs (including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine) have been shown to impair folate absorption and increase the metabolism of circulating folate.
Fluoxetine
Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport system in the intestine.
Decreased folic acid levels have been reported to be associated with the administration of Cholestyramine, Colestipol, Cycloserine, Dihydrofolate Reductase Inhibitors (aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim), L-dopa, colchicine, oral contraceptives, methylprednisolone, pancreatic extracts (pancreatin, pancrelipase), prolonged intravenous pentamidine, smoking and alcohol consumption, sulfasalazine, metformin, heme iron, isotretinoin, and after a 6-month course of therapy, warfarin can produce a significant impairment of folate status.
Thiamin (Vitamin B1)
Furosemide, a loop diuretic, can decrease thiamin levels.
There have been case reports that fluorouracil may increase thiamin metabolism.
Vitamin B6
Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by Vitamin B6. However, Vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Isoniazid can produce a Vitamin B6 deficiency.
Vitamin B12
Antibiotics, cholestyramine, colchicine, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12, and nitrous oxide can produce a functional vitamin B12 deficiency.
Vitamin D3
Some thiazide diuretics, such as hydrochlorothiazide, as well as antacids, bile acid sequestrants (such as cholestyramine), mineral oil, orlistat, olestra, cimetidine, and anticonvulsant medications may reduce the absorption or increase the catabolism of Vitamin D.
Vitamin D supplementation should not be given with calcium to patients with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism or those who form calcium-containing kidney stones.
Iron
Iron supplements might reduce the amounts of levodopa available to the body and diminish its clinical effectiveness.
Levothyroxine ingested simultaneously with iron can result in clinically significant reductions in levothyroxine efficacy.
Proton pump inhibitors reduce the acidity of stomach contents and can reduce iron absorption.
Cupric oxide
Concomitant use of penicillamine and copper can cause decreased absorption of both substances.
Omega-3 Fatty Acids
Ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic effects, and may increase bleeding times.
Avoid administering omega-3 fatty acids to patients with inherited or acquired predisposition toward bleeding, including patients taking anticoagulants. Exercise caution with these patients to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
- PREGNANT AND NURSING MOTHERS
- HEALTH CLAIM
- HOW SUPPLIED
-
STORAGE
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Protect from light and moisture. Dispense in a tight, light-resistant container.
Call your licensed medical practitioner about side effects. You may report side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN
Rx
Manufactured for
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
1-888-848-3593Made in Canada
Rev. 12/2015 - PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label
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INGREDIENTS AND APPEARANCE
VIRT-NATE DHA
ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, ferrous fumarate, magnesium oxide, zinc oxide, cupric sulfate, and omega-3 fatty acids capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69543-370 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 30 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 15 ug FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 28 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION 30 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 mg CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 200 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SOYBEAN OIL (UNII: 241ATL177A) YELLOW WAX (UNII: 2ZA36H0S2V) WATER (UNII: 059QF0KO0R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ETHYL VANILLIN (UNII: YC9ST449YJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69543-370-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/12/2016 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 14 mm imprint Labeler - Virtus Pharmaceuticals (079659493)
