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SetonET

Generic Name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplement
Dosage Form: tablet

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.

SetonET

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13925-100
Packaging
# Item Code Package Description
1 NDC:13925-100-60 1 KIT (1 KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 1 of 2
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 tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 200 mg
IRON (IRON) IRON 29 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 25 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA  
POVIDONE K30  
CITRIC ACID MONOHYDRATE  
POTASSIUM CITRATE ANHYDROUS  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
POLYETHYLENE GLYCOLS  
ETHYLCELLULOSES  
CASTOR OIL  
CORN OIL  
POLYSORBATE 80  
TITANIUM DIOXIDE  
TALC  
FD&C YELLOW NO. 6  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
BROWN IRON OXIDE  
Product Characteristics
Color GREEN (LIGHT GREEN) Score no score
Shape OVAL (OVAL) Size 15mm
Flavor Imprint Code MVC001
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 11/30/2014
Part 2 of 2
DHA SOFTGEL 
omega-3 fatty acids capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 430 mg
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL  
GELATIN  
GLYCERIN  
ETHYL VANILLIN  
WATER  
Product Characteristics
Color yellow (TRANSLUCENT) Score no score
Shape OVAL (OVAL) Size 21mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 11/30/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2009 11/30/2014
Labeler - Seton Pharmaceuticals (828898002)
Revised: 01/2014
 
Seton Pharmaceuticals



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