Cavan-EC SOD DHA

CAVAN-EC SOD DHA — beta 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
Physicians Total Care, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

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 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.”

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

Additional barcode label applied by:
Physicians Total Care, Inc.
Tulsa, OK 74146

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

image of package label
(click image for full-size original)
CAVAN-EC SOD DHA
beta 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
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6158(NDC:13925-122)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6158-0 1 KIT (KIT) in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 6 BLISTER PACK 30
Part 2 6 BLISTER PACK 30
Part 1 of 2
CAVAN-EC SOD DHA
beta 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 tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 130 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 410 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 28 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM) CALCIUM 230 mg
SODIUM FEREDETATE (IRON) IRON 30 mg
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM 25 mg
ZINC OXIDE (ZINC) ZINC 26 mg
CUPRIC OXIDE (COPPER) COPPER 2 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
POVIDONE K30
ACACIA
ASCORBYL PALMITATE
SODIUM ASCORBATE
HYPROMELLOSES
POLYETHYLENE GLYCOL
POLYSORBATE 80
TITANIUM DIOXIDE
TALC
CARNAUBA WAX
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape OVAL (OVAL) Size 22mm
Flavor Imprint Code S122
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 5 TABLET (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2010
Part 2 of 2
CAVAN-EC SOD DHA
omega-3 fatty acids capsule, liquid filled
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 440 mg
Inactive Ingredients
Ingredient Name Strength
ETHYL VANILLIN
Gelatin
Glycerin
Water
SODIUM ALGINATE
STEARIC ACID
SHELLAC
ALCOHOL
DIACETYLATED MONOGLYCERIDES
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
POLYSORBATE 80
FISH OIL (FISH OIL) 628 mg
POTASSIUM SORBATE
Product Characteristics
Color yellow (yellow) Score no score
Shape OVAL (OVAL) Size 22mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 5 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/24/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
VIVA 253288898 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 10/2011 Physicians Total Care, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.