A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid

Rx Only

DESCRIPTION: Cavan One Omega is a prescription prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each maroon soft gelatin capsule for oral administration contains:

Inactive Ingredients:

Aspartic Acid, Carmine Hydrosoluble, Citric Acid, FD&C Blue#1, FD&C Red#40, Fumed Silica, Gelatin, Glycerin, Lecithin, Purified Water, Sorbic Acid, Titanium Dioxide, Vanillin and Yellow Bees Wax.

INDICATIONS:

Cavan One Omega is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception.

CONTRAINDICATIONS:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients including fish and fish oil.

WARNINGS:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. 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

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:

Usual dosage is one capsule daily, or as prescribed by a physician.

HOW SUPPLIED:

Cavan One Omega prenatal/postnatal multivitamin/mineral oblong capsules are maroon soft gelatin capsules, imprinted “TL049”, packaged in bottles of 30 capsules (NDC 13925-080-30).

Storage:

Store at controlled room temperature 15°-30° C (59°-86° F).

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

Reserved for Professional Recommendation

Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401

12/09

SETON PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL:

NDC 13925-080-30

Cavan One Omega

Prenatal Vitamin Supplement with
DHA & EPA and 1 mg Folic Acid

30 Softgel Capsules

Rx Only

SETON PHARMACEUTICALS