VITAPHIL DHA
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beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide, selenium, cupric oxide, choline bitartrate, doconexent
River's Edge Pharmaceuticals, LLC
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VITAPHIL + DHADESCRIPTION:
VitaPhil + DHA and VitaPhil + DHA 90 are high-potency, multivitamin, multi-mineral nutritional supplements with DHA (Omega-3 Fatty Acid).Each VitaPhil + DHA and VitaPhil + DHA 90 caplet contains:
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| Amount Per Serving | % Daily Value |
| Vitamin A (as beta carotene) | 2600 IU | 52% |
| Vitamin C (as ascorbic acid) | 120 mg | 200% |
| Vitamin D3 (cholecalciferol) | 420 IU | 105% |
| Vitamin E (as d-alpha tocopheryl succinate) | 20 IU | 67% |
| Vitamin B1 (as thiamine HCl) | 3 mg | 200% |
| Vitamin B2 (as riboflavin) | 3.5 mg | 205% |
| Vitamin B3 (as niacinamide) | 20 mg | 100% |
| Vitamin B6 (as pyridoxine HCl) | 30 mg | 1500% |
| Folic Acid | 1 mg | 250% |
| Vitamin B12 (as cyanocobalamin) | 12 mcg | 200% |
| Biotin | 30 mcg | 10% |
| Pantothenic Acid (as calcium pantothenate) | 8 mg | 80% |
| Calcium (as calcium carbonate and tricalcium phosphate) | 100 mg | 10% |
| Iron (as ferrous bisglycinate) | 26 mg | 144% |
| Magnesium (as magnesium oxide) | 50 mg | 12% |
| Zinc (as zinc oxide) | 15 mg | 100% |
| Selenium (as sodium selenate) | 50 mcg | 71% |
| Copper (as cupric oxide) | 2 mg | 100% |
| Choline (as choline bitartrate) | 60 mg | * |
| *Daily Value not established. |
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Contains Soy.
Each VitaPhil + DHA and VitaPhil + DHA 90 softgel capsule contains:
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| Amount Per Serving | % Daily Value |
| Docosahexaenoic Acid (DHA) | 200 mg | * |
| *Daily Value not established. |
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May contain Vanillin.
Also contains Eicosapentaenoic Acid (EPA) and other Omega-3 Fatty Acids (from tuna oil).
Cloudiness of the softgel capsule is a characteristic of natural fish oil.
Contains Soy.
Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based by-products.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
VitaPhil + DHA and VitaPhil + DHA 90 supply important prenatal vitamins, minerals and nutrients to supplement the nutritional needs of women, before, during and after pregnancy. Deficiencies of these nutrients are common during pregnancy and lactation and should be prescribed by a physician prior to conception.
VitaPhil + DHA and VitaPhil + DHA 90 caplets are manufactured in a drug-certified cGMP (current good manufacturing practices) facility and meets or exceeds USP standards for potency, purity and dissolution. VitaPhil + DHA and VitaPhil + DHA 90 softgel capsules comply with the most stringent worldwide standards for fish oil and are manufactured in a NSF Certified cGMP Facility.
INDICATIONS AND USAGE:
VitaPhil + DHA and VitaPhil + DHA 90 are indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers and throughout the child bearing years. VitaPhil + DHA and VitaPhil + DHA 90 are also useful in improving the nutritional status prior to conception.
DOSAGE AND ADMINISTRATION:
Before, during and after pregnancy, one caplet and one softgel capsule taken by mouth daily, or as prescribed by a physician. The caplet and softgel capsule 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 (1,000 mg) per day.
CONTRAINDICATIONS:
VitaPhil + DHA and VitaPhil + DHA 90 are contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. These products are contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms.
WARNING:
Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.
Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.
PRECAUTIONS:
Folic acid in dosages above 400 mcg daily may obscure megaloblastic (pernicious) anemia in that hematological remission can occur while neurological manifestations (Addisonian anemia) remain progressive.
ADVERSE REACTIONS:
Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, VitaPhil + DHA and VitaPhil + DHA 90 when taken after meals, may control occasional G.I. disturbances. VitaPhil + DHA and VitaPhil + DHA 90 are best absorbed when taken at bedtime.
Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.
USE IN SPECIFIC POPULATIONS:
VitaPhil + DHA and VitaPhil + DHA 90 are not advocated for pediatric or geriatric use.
OVERDOSE:
Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities have resulted. VitaPhil + DHA and VitaPhil + DHA 90 should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.
HOW SUPPLIED:
VitaPhil + DHA (NDC 68032-341-60): A 30-day regimen supplied as one bottle containing 30 green VitaPhil + DHA Prenatal capsule-shaped caplets NDC: 68032-496-30 imprinted “RE 341” and one bottle containing 30 pale yellow DHA softgel capsules NDC: 68032-497-30. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures.
VitaPhil + DHA 90 (NDC 68032-342-18): A 90-day regimen supplied as one bottle containing 90 green VitaPhil + DHA 90 Prenatal capsule-shaped caplets NDC: 68032-498-90 imprinted “RE 341” and one bottle containing 90 pale yellow DHA softgel capsules NDC: 68032-499-90. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures.
Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.
CAUTION: Rx Only
Manufactured for:
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 03/10 341/342-11
PACKAGING:
| VITAPHIL DHA
beta carotene, ascorbic acid, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, magnesium oxide, zinc oxide, selenium, cupric oxide, choline bitartrate, doconexent kit |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 11/14/2008 | 12/31/2011 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |