SE-NATAL ONE- vitamin a acetate, cholecalciferol, .alpha.-tocopherol, dl, niacinamide ascorbate, folic acid, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, ferrous fumarate, magnesium oxide, cupric oxide and zinc oxide 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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Se-Natal ONE
(One Tablet Daily)
Prenatal Multivitamin/Mineral Tablets
DESCRIPTION
Se-Natal ONE is an capsule shaped, off-white coated tablet imprinted “MVC-007” on one side, and provides 12 vitamins and 5 minerals to supplement the diet during pregnancy or lactation.
| Each Se-Natal ONE tablet contains: | |
|---|---|
| Vitamin A (Acetate 3600 I.U. and Beta Carotene 400 I.U.) | 4000 I.U. |
| Vitamin D3 (Cholecalciferol) | 400 I.U. |
| Vitamin E (dI-alpha-tocopheryl acetate) | 15 I.U. |
| Vitamin C (ascorbic acid and niacinamide ascorbate) | 80 mg |
| Folic Acid | 1 mg |
| Vitamin B1 (as thiamine HCl) | 1.5 mg |
| Vitamin B2 (riboflavin) | 1.6 mg |
| Niacinamide | 17 mg |
| Vitamin B6 (pyridoxine HCl) | 4 mg |
| Vitamin B12 (cyanocobalamin) | 2.5 mcg |
| Biotin | 30 mcg |
| Pantothenic Acid | 7 mg |
| Calcium (calcium carbonate) | 200 mg |
| Iron (ferrous fumarate) | 60 mg |
| Magnesium (magnesium oxide) | 100 mg |
| Copper (cupric oxide) | 3 mg |
| Zinc (zinc oxide) | 25 mg |
Inactive Ingredients:
PVP K30, Fumed Silica, Citric Acid, TriPotassium Citrate, Microcrystalline Cellulose, Croscarmellose Sodium, Ascorbyl Palmitate, Stearic Acid, Magnesium Stearate, and Gum Arabic.
INDICATIONS AND USAGE
Se-Natal ONE tablets help assure an adequate intake of the vitamins and minerals listed. Folic acid helps prevent the development of megaloblastic anemia during pregnancy.
CONTRAINDICATIONS
Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson’s disease.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
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.
General:
Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. The calcium content should be considered before prescribing for patients with kidney stones. Do not exceed the recommended dose.
Geriatric Use:
Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
These tablets are partially bisected for breaking, to ease administration only. Take one tablet daily or as prescribed by a physician.
Dispense in a tight, light-resistant container with a child resistant closure.
Store at controlled room temperature 15°-30°C (59°-86°F).
Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Rx Only
Reserved for Professional Recommendation
Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA
Rev. NOV-2010
SETON PHARMACEUTICALS
| SE-NATAL ONE
vitamin a acetate, cholecalciferol, .alpha.-tocopherol, dl, niacinamide ascorbate, folic acid, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, pantothenic acid, calcium carbonate, ferrous fumarate, magnesium oxide, cupric oxide and zinc oxide tablet |
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| Labeler - Seton Pharmaceuticals (828898002) |
| Registrant - Seton Pharmaceuticals (828898002) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| VIVA | 253288898 | MANUFACTURE(13925-103) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Rainbow Gold | 800695152 | REPACK(13925-103) | |