Virt-BAL DHA Plus
Name: Virt-BAL DHA Plus
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil.
Warnings
| 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. |
WARNING: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.
Virt-BAL DHA Plus Dosage and Administration
Before, during, and after pregnancy, one tablet and one softgel capsule, taken by mouth daily, or as directed by a licensed medical practitioner. Tablets and softgel capsules may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1000 mg) per day.
PRINCIPAL DISPLAY PANEL - 30 Tablet / 30 Softgel Kit Carton
VIRTUS
PHARMACEUTICALS
Product Code* 76439-225-60
Virt-BAL DHA Plus
PRENATAL / POSTNATAL
Prescription Folate
30 Tablets / 30 Softgels
Rx
Virt-BAL DHA Plus
folic acid, pyridoxine, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate hydrochloride, iodine, zinc oxide, cupric oxide, .beta.-carotene, magnesium oxide, doconexent, and icosapent kit |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:76439-225 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:76439-225-60 | 1 KIT in 1 CARTON | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | 1 BLISTER PACK | 30 | | Part 2 | 1 BLISTER PACK | 30 | |
| Part 1 of 2 | Virt-BAL DHA Plus
folic acid, pyridoxine, calcium carbonate, sodium ascorbate, cholecalciferol, acetate ion, thiamine mononitrate, riboflavin, niacinamide, cyanocobalamin, ferrous bisglycinate hydrochloride, iodine, zinc oxide, cupric oxide, .beta.-carotene, and magnesium oxide tablet | |
| Product Information | | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Folic Acid (Folic Acid) | Folic Acid | 1 mg | | Pyridoxine (Pyridoxine) | Pyridoxine | 50 mg | | Calcium Carbonate (Calcium cation) | Calcium Carbonate | 219 mg | | Sodium Ascorbate (Ascorbic Acid) | Sodium Ascorbate | 120 mg | | Cholecalciferol (Cholecalciferol) | Cholecalciferol | 840 [iU] | | Acetate Ion (Acetate Ion) | Acetate Ion | 3 mg | | Thiamine Mononitrate (Thiamine Ion) | Thiamine Mononitrate | 1.8 mg | | Riboflavin (Riboflavin) | Riboflavin | 4 mg | | Niacinamide (Niacinamide) | Niacinamide | 20 mg | | Cyanocobalamin (Cyanocobalamin) | Cyanocobalamin | 12 ug | | Ferrous Bisglycinate Hydrochloride (Ferrous Cation) | Ferrous Bisglycinate Hydrochloride | 26.49 mg | | Iodine (Iodine) | Iodine | 220 ug | | Zinc Oxide (Zinc Oxide) | Zinc Oxide | 25 mg | | Cupric Oxide (Cupric Oxide) | Cupric Oxide | 2 mg | | .Beta.-Carotene (.Beta.-Carotene) | .Beta.-Carotene | 2850 [iU] | | Magnesium Oxide (Magnesium Cation) | Magnesium Oxide | 25 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | Acacia | | | Croscarmellose Sodium | | | 1,2-Dibromo-3-Chloropropane | | | Citric Acid Monohydrate | | | Magnesium Stearate | | | Cellulose, Microcrystalline | | | FD&C Blue No. 1 | | | FD&C Yellow No. 5 | | | FD&C Yellow No. 6 | | | Aluminum Oxide | | | Hypromelloses | | | Polyethylene Glycols | | | Polyvinyl Alcohol | | | Talc | | | Titanium Dioxide | | | Povidone K30 | | | Stearic acid | | | Potassium Citrate Anhydrous | | |
| Product Characteristics | | Color | YELLOW | Score | no score | | Shape | OVAL | Size | 20mm | | Flavor | | Imprint Code | VTAB | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | | 30 TABLET in 1 BLISTER PACK | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 07/12/2012 | | |
| Part 2 of 2 | Virt-BAL DHA Plus
doconexent and icosapent capsule, gelatin coated | |
| Product Information | | | Route of Administration | ORAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Doconexent (Doconexent) | Doconexent | 262 mg | | Icosapent (Icosapent) | Icosapent | 112 mg | |
| Inactive Ingredients | | Ingredient Name | Strength | | Gelatin | | | .Alpha.-Tocopherol | | | Glycerin | | | Water | | | Sodium Alginate | | | Stearic Acid | | | Shellac | | | Diacetylated Monoglycerides | | | Polysorbate 80 | | | Potassium Sorbate | | |
| Product Characteristics | | Color | YELLOW (light-yellow) | Score | no score | | Shape | CAPSULE | Size | 20mm | | Flavor | | Imprint Code | | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | | 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 07/12/2012 | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved drug other | | 07/12/2012 | | |
| Labeler - Virtus Pharmaceuticals (969483143) |
Revised: 09/2012 Virtus Pharmaceuticals
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Black, tarry, or bloody stools.
- Fever.
- Very upset stomach or throwing up.
- Very bad belly pain.
- Throwing up blood or throw up that looks like coffee grounds.
- Stomach cramps.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Hard stools (constipation).
- Upset stomach or throwing up.
- Change in color of stool to green.
- Loose stools (diarrhea).
- Belly pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Some side effects of Virt-Bal DHA Plus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
