Prescribing information (package insert) - Se-Natal 19 Chewable
DESCRIPTION
Se·Natal 19 Chewable tablets are round, debossed "TL015." These tablets provide oil-soluble vitamins, water-soluble vitamins and minerals. Each tablet contains:
Supplement Facts
| Servings per Bottle: | 100 | %DV For Pregnant and Lactating Women |
| Serving Size | 1 chewable tablet | |
| Each Tablet contains: | ||
| Vitamin A (as beta carotene) | 1000 IU | 23% |
| Vitamin C (calcium ascorbate) | 100 mg | 83% |
| Vitamin D (as cholecalciferol) | 10 mcg | 67% |
| Vitamin E (as dl-alpha tocopherol acetate) | 30 IU | 142% |
| Thiamine (Vitamin B1) | 3 mg | 214% |
| Riboflavin (Vitamin B2) | 3 mg | 188% |
| Niacin (as niacinamide) | 15 mg | 83% |
| Vitamin B6 (as pyridoxine HCl) | 20 mg | 1000% |
| Folate (folic acid) | 1000 mcg | 167% |
| Vitamin B12 (as cyanocobalamin) | 12 mcg | 429% |
| Pantothenic Aicd (as calcium pantothenate) | 7 mg | 100% |
| Calcium (as calcium carbonate) | 200 mg | 15% |
| Iron (as ferrous fumarate) | 29 mg | 107% |
| Zinc (as zinc oxide) | 20 mg | 154% |
CLINICAL PHARMACOLOGY
Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemogloblin syntheis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megablastic macrocytic anemias. Vitamin B12 is essential to growth cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia.
OTHER INGREDIENTS
Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.
INDICATIONS AND USAGE
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.
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
GENERAL
Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.
Folic Acid
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia. In that hematologic remission can occur while neurological manifestations remain progressive.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range.
ADVERSE REACTIONS
Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DRUG INTERACTIONS
Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
OVERDOSAGE
Symptoms:
Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.
DOSAGE AND ADMINISTRATION
One tablet daily, or as directed by a physician.
NOTICE
Contact with moisture can discolor or erode the tablet.
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.
Product Code: 13925-117-01
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)[See USP controlled room temperature].
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.
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
Code 640138
Rev. 03/24
SETON PHARMACEUTICALS