Cavan-EC SOD DHA
Cavan-EC SOD DHA
FULL PRESCRIBING INFORMATION: CONTENTS*
- CAVAN-EC SOD DHA DESCRIPTION
- INDICATIONS
- CAVAN-EC SOD DHA CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DRUG INTERACTIONS
- CAVAN-EC SOD DHA ADVERSE REACTIONS
- CAVAN-EC SOD DHA DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY
FULL PRESCRIBING INFORMATION
PRENATAL VITAMIN
Rx Only
CAVAN-EC SOD DHA 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.
CAVAN-EC SOD DHA 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 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.
CAVAN-EC SOD DHA ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
CAVAN-EC SOD DHA 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 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.”
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 blisters 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
Cavan-EC SOD DHABeta 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, Iodine, Omega-3 Fatty Acids KIT
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