Alpha-tocopherol Acetate 30 Unt / Ascorbic Acid 100 Mg / Beta Carotene 1000 Unt / Calcium Carbonate 200 Mg / Calcium Pantothenate 7 Mg / Cholecalciferol 400 Unt / Docusate Sodium 25 Mg / Ferrous Fumarate 29 Mg / Folic Acid 1 Mg / Niacinamide 15 Mg / Pyridoxine Hydrochloride 20 Mg / Riboflavin 3 Mg / Thiamine 3 Mg / Vitamin B12 0.012 Mg / Zinc Oxide 20 Mg Oral Tablet
Vitamins & Minerals with Folic Acid
Rx Only
DESCRIPTION
Se-Natal 19 is a white, oblong, film coated tablet, debossed "TL 019". Each film coated tablet contains:
| Servings per Bottle: 100 | ||
| Serving Size: 1 tablet | ||
| Each Tablet contains: | % DV for Pregnant and Lactating Women | |
| Vitamin A (as beta carotene) | 1000 IU | 23% |
| Vitamin C (ascorbic acid) | 100 mg | 83% |
| Vitamin D (as cholecalciferol) | 10 mcg | 67% |
| Vitamin E (as dl-alpha tocoperol 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 Acid (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% |
Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.
INDICATIONS AND USAGE
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.
PREGNANCY
Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
Safety and effectiveness in pediatric patients have not been established.
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
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.
Contact with moisture can discolor or erode the tablet. Do not chew tablet.
HOW SUPPLIED/STORAGE AND HANDLING
Se-Natal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019", packaged in bottles of 100 tablets.
Product Code: 13925-116-01.
Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP controlled room temperature].
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.
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
Code 116-01
Rev. 03/18
SETON PHARMACEUTICALS
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