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:

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.

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.

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 54868-6158-0.

Cavan-EC SOD DHA is supplied in child-resistant blister 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.”

PACKAGE LABEL.PRINCIPAL DISPLAY

NDC 54868-6158-0

Cavan-EC SOD
DHA

PRENATAL VITAMINS

Enteric-Coated:

R x Only

30-Day Supply
30 Tablets and 30 Softgel Capsules