FDA Label for Se-natal 19
View Indications, Usage & Precautions
Se-natal 19 Product Label
The following document was submitted to the FDA by the labeler of this product Seton Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Vitamins & Minerals with Folic Acid
Rx Only
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.
Reserved for Professional Recommendation.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA
Rev. 02/14
SETON PHARMACEUTICALS
Description
Se-Natal 19 provides oil soluble vitamins, water-soluble vitamins and minerals.
| Each tablet contains: | |
| Vitamin A (as beta carotene) | 1000 IU |
| Vitamin C (ascorbic acid) | 100 mg |
| Vitamin D (as cholecalciferol) | 400 IU |
| Vitamin E (as dl-alpha tocopheryl acetate) | 30 IU |
| Thiamine (Vitamin B1) | 3 mg |
| Riboflavin (Vitamin B2) | 3 mg |
| Niacin (as niacinamide) | 15 mg |
| Vitamin B6 (as pyridoxine HCI) | 20 mg |
| Folate (folic acid) | 1 mg |
| Vitamin B12 (as cyanocobalamin) | 12 mcg |
| Pantothenic Acid (as calcium pantothenate) | 7 mg |
| Calcium (as calcium carbonate) | 200 mg |
| Iron (as ferrous fumarate) | 29 mg |
| Zinc (as zinc oxide) | 20 mg |
| Docusate Sodium | 25 mg |
Other Ingredients
Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.
Indications
Se-Natal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 tablets are also useful 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.
Boxed Warning
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.
Dosage And Administration
One tablet daily, or as directed by a physician.
How Supplied
Se-Natal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019", packaged in bottles of 100 tablets.
NDC 13925-116-01.
Storage
Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.
Pharmacist
Dispense in a tight, light-resistant container as defined in the USP/NF with child-resistant closure.
Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Package Label.Principal Display Panel
NDC 13925-116-01
Se-Natal 19
Tablets
Vitamins and Minerals with Folic Acid
100 Tablets
Rx Only
SETON
PHARMACEUTICALS
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