CAVAN PRENATAL
-
thiamine mononitrate,
riboflavin,
pyridoxine hydrochloride,
cyanocobalamin,
ascorbic acid,
niacin,
folic acid,
ferrous fumarate,
calcium carbonate,
cholecalciferol,
.alpha.-tocopherol,
potassium iodide,
zinc oxide and
choline bitartrate tablet
Seton Pharmaceuticals
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.
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Description:
Cavan Prenatal TAB with EC Calcium is a white coated, caplet-shaped tablet with “TL011” debossed. The formulation has been designed to avoid interference of calcium and iron absorption through a pH-dependent biphasic release of these minerals at different sites in the gastrointestinal tract. The immediate-release iron dissolves at gastric pH, while the delayed-release enteric coated calcium granules dissolve in the small intestine at a pH of 5.5 or higher.
| Each tablet contains: | |
|---|---|
| Ingredient | Dose |
| Vitamin B1 (thiamin mononitrate) | 3 mg |
| Vitamin B2 (riboflavin universal) | 3 mg |
| Vitamin B6 (pyridoxine HCI) | 50 mg |
| Vitamin B12 (cyanocobalamin) | 8 mcg |
| Vitamin C (ascorbic acid) | 120 mg |
| Niacin (niacinamide) | 20 mg |
| Folic acid | 1 mg |
| Iron (ferrous fumarate) | 28 mg |
| Calcium (calcium carbonate) | 200 mg |
| Vitamin D (vitamin D3) | 420 IU |
| Vitamin E (vitamin E 500) | 30 IU |
| Iodine (potassium iodide) | 150 mcg |
| Zinc (zinc oxide) | 15 mg |
| Choline (choline bitartrate) | 55 mg |
Inactive Ingredients:
Dicalcium Phosphate, Microcrystalline Cellulose, Stearic Acid, Magnesium Trisillicate, Magnesium Stearate, and Pharmaceutical Glaze.
Indications and Usage:
Cavan Prenatal TAB with EC Calcium is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Cavan Prenatal TAB with EC Calcium is also beneficial in improving the nutritional status of women prior to conception.
Contraindications:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Precautions:
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Adverse Reactions:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
How Supplied:
Cavan Prenatal TAB with EC Calcium tablets for oral administration are supplied as white coated caplet-shaped tablets with “TL011” debossed in bottles of 90 tablets.
NDC 13925-106-90.
Pharmacist: Dispense in a tight, light-resistant container as defined in the USP.
Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
Reserved for Professional Recommendation
Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
08/09
SETON
PHARMACEUTICALS
PRINCIPAL DISPLAY PANEL: - 90 tablets
NDC 13925-106-90
Cavan Prenatal TAB
with EC Calcium
Prenatal Multi-vitamin/Mineral Tablets
90 Tablets
Rx Only
SETON
PHARMACEUTICALS
| CAVAN PRENATAL
thiamin mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, .alpha.-tocopherol, potassium iodide, zinc oxide and choline bitartrate tablet |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 07/09/2009 | 07/22/2009 | |
| Labeler - Seton Pharmaceuticals (828898002) |
| Registrant - Seton Pharmaceuticals (828898002) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Rainbow Gold | 800695152 | REPACK | |
Revised: 08/2012 Seton Pharmaceuticals