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SetonET-EC DHA

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

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-EC DHA

Rx Only

DESCRIPTION:

SetonET-EC DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and enteric-coated softgel capsules.

Each green oval SetonET-EC Tablet contains:

VITAMINS
A (beta carotene) 3,000 IU
C (ascorbic acid) 120 mg
D (cholecalciferol) 400 IU
E (dl-alpha tocopheryl acetate) 3 mg
B1 (thiamine mononitrate) 1.8 mg
B2 (riboflavin) 4 mg
Niacinamide 20 mg
B6 (pyridoxine HCI) 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 frosted, clear, oval enteric-coated 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-EC Tablet): Ethyl Cellulose, FD&C Blue #1 Lake, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, Fumed Silica, Hypromellose, Iron Oxide Brown, Kollidon 30, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Talc, Titanium Dioxide, Vegetable Oil.

OTHER INGREDIENTS (Enteric-coated DHA softgel capsule): Acetylated Monoglycerides, Ethyl Vanillin, Gelatin, Glycerin, Polysorbate 80, Potassium Sorbate, Purified Water, Shellac Ammonium Salt, Sodium Alginate, Specially Denatured Alcohol, Stearic Acid, Vitamin E.

INDICATIONS:

SetonET-EC DHA 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-EC DHA 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.

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 a poison control center immediately.

THIS PRODUCT CONTAINS FISH OIL.

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.

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 enteric-coated softgel capsule taken by mouth daily, or as directed by a physician. The tablet and enteric-coated 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 1gram (1,000 mg) per day.

HOW SUPPLIED:

SetonET-EC DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 SetonET-EC tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 6 cards with 5 unit-doses per card which is a 30-day supply. SetonET-EC is a green oval tablet debossed with “MVC-005”. The enteric-coated DHA softgel capsule is frosted colorless and oval. Unit dose blisters are child-resistant to opening as a safeguard against ingestion by children. NDC 13925-101-60

STORAGE:

Store at USP controlled room temperature 20-25°C (68-77°F). Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration 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

Manufactured For:

Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401

Made In Canada          07/11

SETON PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules

NDC 13925-101-60

SetonET-EC
DHA
Prenatal Vitamins

Enteric-Coated

Rx Only

30-day supply -

30 tablets and 30 softgel capsules

SETONET-EC 
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:13925-101
Packaging
# Item Code Package Description
1 NDC:13925-101-60 1 KIT (1 KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 30 
Part 2 30 
Part 1 of 2
SETONET-EC 
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 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- 3 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 CATION 200 mg
FERROUS BISGLYCINATE HYDROCHLORIDE (FERROUS CATION) FERROUS CATION 29 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 25 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSES  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 5  
FD&C YELLOW NO. 6  
SILICON DIOXIDE  
HYPROMELLOSES  
BROWN IRON OXIDE  
POVIDONE K30  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POLYSORBATE 80  
TALC  
TITANIUM DIOXIDE  
CORN OIL  
Product Characteristics
Color GREEN Score no score
Shape OVAL (OVAL) Size 19mm
Flavor Imprint Code MVC005
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
SETONET-EC-DHA 
omega-3 fatty acids capsule, liquid filled
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
DIACETYLATED MONOGLYCERIDES  
ETHYL VANILLIN  
GELATIN  
GLYCERIN  
POLYSORBATE 80  
POTASSIUM SORBATE  
WATER  
SHELLAC  
SODIUM ALGINATE  
ALCOHOL  
STEARIC ACID  
ALPHA-TOCOPHEROL  
Product Characteristics
Color YELLOW (Frosted colorless) Score no score
Shape OVAL (OVAL) Size 23mm
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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