Other
A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation
Rx Only
Se-natal 19 Chewable Tablet, Chewable
FDA Label NDC 13925-117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Seton Pharmaceuticals for the product Se-natal 19 Chewable (NDC 13925-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description, inactive ingredients, indications, contraindications, warnings, boxed warning, precautions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
Se·Natal 19 Chewable tablets are round, debossed "TL015." These tablets provide oil-soluble vitamins, water-soluble vitamins and minerals.
| Each tablet has the following active ingredient: Folate | |
| (folic acid) | 1 mg |
| Each tablet also contains the following ingredients for nutritional supplement: | |
| Vitamin A (as beta carotene) | 1000 IU |
| Vitamin C (calcium ascorbate) | 100 mg |
| Vitamin D3 (as cholecalciferol) | 400 IU |
| Vitamin E (as dl-alpha tocopheryl acetate) | 30 IU |
| Thiamine (Vitamin B1) (thiamine mononitrate) | 3mg |
| Riboflavin (Vitamin B2) | 3 mg |
| Niacinamide (Vitamin B3) | 15 mg |
| Vitamin B6 (as pyridoxine HCI) | 20 mg |
| Vitamin B12 (as cyanocobalamin) | 12 mcg |
| Pantothenic Acid (as D Calcium Pantothenate) | 7 mg |
| Calcium (as calcium carbonate) | 200 mg |
| Iron (as ferrous fumarate) | 29 mg |
| Zinc (as zinc oxide) | 20 mg |
Inactive Ingredients
Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.
Indications
Se-Natal 19 Chewable 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 Chewable 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 0.8 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 Chewable Tablets for oral administration are supplied as multi-color-speckled, round tablets debossed "TL015," packaged in bottles of 100 tablets.
NDC 13925-117-01
Storage
Store at 20°-25°C (68°-77°F [see USP controlled room temperature]. Protect from moisture and excessive heat. Avoid freezing.
Pharmacist
Dispense in a tight, light-resistant container as defined in the USP/INF with child-resistant closure.
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
Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA
08/13
SETON PHARMACEUTICALS
Package Label.Principal Display Panel
NDC 13925-117-01
Se-Natal 19 Chewable
Tablets
A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation
Rx Only
100 Tablets
SETON
PHARMACEUTICALS
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