Cavan-EC SOD DHA (beta carotene 3000 [iu] ascorbic acid 130 mg cholecalciferol 410 [iu] .alpha.-tocopherol 30 mg thiamine mononitrate 1.8 mg riboflavin 4 mg niacinamide 20 mg pyridoxine hydrochloride 28 mg folic acid 1 mg cyanocobalamin 12 ug calcium 230 mg sodium feredetate 30 mg magnesium 25 mg zinc 26 mg copper 2 mg) Dailymed

PRENATAL VITAMIN

Rx Only

Description

CAVAN-EC SOD DHA with enteric-coated omega-3 is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids, supplied as tablets and enteric-coated softgel capsules.

Each yellow oval Cavan-EC SOD DHA Tablet contains:

VITAMINS
A (beta carotene)	3,000 IU
C (ascorbic acid)	130 mg
D (cholecalciferol)	410 IU
E (dl-alpha tocopheryl acetate)	30 mg
B1 (thiamine mononitrate)	1.8 mg
B2 (riboflavin)	4 mg
Niacinamide	20 mg
B6 (pyridoxine hydrochloride)	28 mg
Folic acid	1 mg
B12 (cyanocobalamin)	12 mcg
MINERALS
Calcium (calcium carbonate)	230 mg
Iron (sodium iron EDTA)	30 mg
Magnesium (magnesium oxide)	25 mg
Zinc (zinc oxide)	26 mg
Copper (cupric oxide)	2 mg

Each clear oval enteric-coated DHA Softgel Capsule contains a clear solution with at least 440 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid) and DPA (docasapentaenoic acid) in at least 628 mg of fish oil.

OMEGA-3 FATTY ACIDS
Total omega-3 long chain fatty acids	at least 440 mg
As DHA	at least 295 mg
As other omega-3 long-chain fatty acids	at least 145 mg

OTHER INGREDIENTS

(Cavan-EC SOD DHA Tablet): Microcrystalline Cellulose, Corn Starch, Fumed Silica, Magnesium Stearate, Croscarmellose Sodium, PVP-K30 (Kollidon 30), Gum Arabic EQ, Ascorbyl Palmitate, Di Cal Phosphate, Sodium Ascorbate, Hypromellose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide, Talc, Carnauba Wax, FD&C Yellow #5, FD&C Blue #1.

OTHER INGREDIENTS (Cavan-EC SOD DHA Softgel Capsule): Ethyl Vanillin, Gelatine, Glycerine, Purified Water, Sodium Alginate, Stearic Acid, Shellac ammonium salt, specialty denatured alcohol, Acetylated Monoglycerides, Polysobate 80, Potassium Sorbate.

Indications

Cavan-EC SOD 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. Cavan-EC SOD 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.

Boxed Warning Section

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.

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 1 gram (1,000 mg) per day.

How Supplied

NDC 13925-122-60. Cavan-EC SOD DHA is supplied in child-resistant buler cards containing 30 doses per carton (1 Cavan-EC SOD DHA 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. The yellow oval Cavan-EC SOD DHA tablet is imprinted with “S122.”

STORAGE

Store at 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.

DISPENSING

Keep in a well-closed, light-resistant container as defined by the USP. Unit dose bulers are child-resistant to opening as a safeguard against ingestion by children.

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

Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736

MADE IN CANADA

SETON PHARMACEUTICALS

Package Label.principal Display

NDC 13925-122-60

Cavan-EC SOD DHA

PRENATAL VITAMINS

Enteric-Coated:

R _x Only

30-Day Supply 30 Tablets and 30 Softgel Capsules