CAVAN HEME OB
-
folic acid,
cholecalciferol,
.alpha.-tocopherol succinate, d-,
thiamine mononitrate,
riboflavin,
niacin,
pyridoxine hydrochloride,
cyanocobalamin,
biotin,
calcium pantothenate ,
iron,
potassium iodide,
zinc oxide,
sodium selenate and
cupric sulfate tablet
Seton Pharmaceuticals
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.
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Cavan™-Heme OB is an orally administered prescription vitamin/medical food.
Each tablet contains the following Dietary Ingredients: | |
---|---|
Folate1 | 1 mg |
Vitamin D3 (as cholecalciferol) | 400 IU |
Vitamin E (as d-alpha tocopheryl succinate) | 10 IU |
Vitamin B1 (as thiamine mononitrate) | 1.5 mg |
Vitamin B2 (as riboflavin) | 1.6 mg |
Vitamin B3 (niacin as niacinamide) | 17 mg |
Vitamin B6 (as pyridoxine HCI) | 50 mg |
Vitamin B12 (as cyanocobalamin) | 12 mcg |
Biotin | 30 mcg |
Vitamin B5 (as d-calcium pantothenate) | 10 mg |
Iron | 28 mg |
Iodine (as potassium iodide) | 175 mcg |
Zinc (as zinc oxide) | 15 mg |
Selenium (as sodium selenate) | 65 mcg |
Copper (as cupric sulfate) | 0.8 mg |
Folate1, Vitamin D3 (as cholecalciferol), Vitamin E (as d-alpha tocopheryl succinate), Vitamin B1 (as thiamin mononitrate), Vitamin B2 (as riboflavin), Vitamin B3 (niacin as niacinamide), Vitamin B6 (as pyridoxine HCI), Vitamin B12 (as cyanocobalamin), Biotin, Vitamin B5 (as d-calcium pantothenate), Iron, Iodine (as potassium iodide), Zinc (as zinc oxide), Selenium (as sodium selenate), Copper (as cupric sulfate), Gum Arabic, PVP K30, Microcrystalline Cellulose, Citric Acid, TriPotassium Citrate, Croscarmellose Sodium, Fumed Silica, Magnesium Stearate, Stearic Acid, Hypromellose, Polyethylene Glycol, Titanium Dioxide, Talc, Black Iron Oxide, Carmine, Vegetable Oil, and Polysorbate 80.
Cavan™-Heme OB is an orally administered prescription vitamin/medical food indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of dietary supplementation. Cavan™-Heme OB should always be used under medical supervision.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
Cavan™-Heme OB is a prescription vitamin/medical food for use only under medical supervision and direction.
Drugs which may interact with folate include:
Drugs which may interact with pyridoxine hydrochloride:
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.
One tablet daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.
Cavan™-Heme OB is supplied as purple, oval tablets with “S128” debossed on one side, dispensed in bottles of 90 tablets.
Product Code: 13925-128-902
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F) [See current USP]. Dispense in a tight, light-resistant container to protect from light and moisture.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
Reserved for Professional Recommendation
Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
Manufactured For:
Seton Pharmaceuticals,
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA
Rev.7/10
SETON
PHARMACEUTICALS
NDC 13925-128-90
Cavan TM- Heme OB
Tablets
Rx Only
90 Tablets
SETON
PHARMACEUTICALS
CAVAN HEME OB
folic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, iron, potassium iodide, zinc oxide, sodium selenate and cupric sulfate tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved drug other | 08/03/2010 | 06/10/2012 |
Labeler - Seton Pharmaceuticals (828898002) |
Registrant - Seton Pharmaceuticals (828898002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
VIVA | 253288898 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Operations |
Rainbow Gold | 800695152 | REPACK |
Revised: 08/2012 Seton Pharmaceuticals