SetonET
SetonET
FULL PRESCRIBING INFORMATION: CONTENTS*
- SETONET DESCRIPTION:
- INDICATIONS:
- SETONET CONTRAINDICATIONS:
- WARNINGS:
- PRECAUTIONS:
- DRUG INTERACTIONS:
- SETONET ADVERSE REACTIONS:
- SETONET DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules
FULL PRESCRIBING INFORMATION
Rx Only
DESCRIPTION:
SetonET is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules.
Each light green oblong SetonET Tablet* contains:
| VITAMINS | |
|---|---|
| A (beta carotene) | 3,000 IU |
| C (ascorbic acid) | 120 mg |
| D (cholecalciferol) | 400 IU |
| E (dl-alpha tocopheryl acetate) | 30 mg |
| B1 (thiamine mononitrate) | 1.8 mg |
| B2 (riboflavin) | 4 mg |
| Niacinamide | 20 mg |
| B6 (pyridoxine hydrochloride) | 25 mg |
| Folic acid | 1 mg |
| B12 (cyanocobalamin) | 12 mcg |
| MINERALS | |
| Calcium (calcium carbonate) | 200 mg |
| Iron (ferrous bisglycinate HCl and iron protein succinylate) |
29 mg |
| Magnesium (magnesium oxide) | 25 mg |
| Zinc (zinc oxide) | 25 mg |
| Copper (cupric oxide) | 2 mg |
Each translucent oblong DHA Softgel Capsule* contains:
430 mg purified omega-3 fatty acids including: At least 295 mg DHA (docosahexaenoic acid); also contains EPA (eicosapentaenoic acid) and other omega-3 fatty acids.
OTHER INGREDIENTS (SetonET Tablet): Gum Arabic, PVP K30, Citric Acid, TriPotassium Citrate, Microcrystalline Cellulose, Fumed Silica, Magnesium Stearate, Croscarmellose Sodium, Hypromellose, Polyethylene Glycol, Ethyl Cellulose, Vegetable Oil, Polysorbate 80, Titanium Dioxide, Talc, FD&C Yellow #6 Lake, FD&C Blue #1 Lake, FD&C Yellow #5 Lake, Brown Iron Oxide.
*USP Compliance: SetonET tablet is formulated in conformance with official U.S. Pharmacopeia (USP) standards of quality for potency, purity and dissolution. DHA softgel capsule complies with the standards and methods outlined in the CRN Voluntary Monograph for potency and purity.
INDICATIONS:
SetonET is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. SetonET is also useful in improving nutritional status prior to conception.
CONTRAINDICATIONS:
This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish or fish oil.
WARNINGS:
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
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.
PRECAUTIONS:
Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).
DRUG INTERACTIONS:
Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
ADVERSE REACTIONS:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION:
Before, during and after pregnancy, one tablet and one softgel capsule taken by mouth daily, or as directed by a physician. The tablet 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.
HOW SUPPLIED:
SetonET is supplied in a carton containing 30 tablets and 30 softgels in blister cards. SetonET is a light green oblong tablet imprinted with “MVC-001”. The DHA softgel capsule is a translucent oblong softgel capsule. Unit dose blisters are child-resistant to opening, as a safeguard against ingestion by children. NDC 13925-100-60.
STORAGE:
20°-25°C (68°-77°F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations of the tablet.
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
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA
06/10
SETON PHARMACEUTICALS
PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules
NDC 13925-100-60
SetonET
PRENATAL VITAMINS
High potency nutrition
with an easy-to-tolerate iron
formulation, plus DHA,
an Omega-3 fatty acid
Rx Only
PRENATAL VITAMINS
30-Day Supply
30 Tablets and 30 Softgel Capsules
SETON PHARMACEUTICALS
SetonET beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium oxide, zinc oxide, cupric oxide,omega-3 fatty acids KIT
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