SetonET-EC

Seton Pharmaceuticals

SetonET-EC DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• SETONET-EC DESCRIPTION:
• INDICATIONS:
• SETONET-EC CONTRAINDICATIONS:
• WARNINGS:
• PRECAUTIONS:
• DRUG INTERACTIONS:
• SETONET-EC ADVERSE REACTIONS:
• SETONET-EC DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
  • STORAGE:
• PRINCIPAL DISPLAY PANEL - 30 Tablets and 30 Softgel Capsules

FULL PRESCRIBING INFORMATION

R_x 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:

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.

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

R_x Only

30-day supply -

30 tablets and 30 softgel capsules