Se-Natal 19
Se-Natal 19 Tablets
635104e6-6a53-4684-ac9a-7ac31b33083d
HUMAN PRESCRIPTION DRUG LABEL
Feb 12, 2024
Seton Pharmaceuticals
DUNS: 828898002
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium pantothenate, calcium carbonate, ferrous fumarate, zinc oxide and docusate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (26)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
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 SECTION
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
ADVERSE REACTIONS SECTION
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 SECTION
DRUG INTERACTIONS
Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
SPL UNCLASSIFIED SECTION
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
DESCRIPTION SECTION
DESCRIPTION
Se-Natal 19 is a white, oblong, film coated tablet, debossed "TL 019". Each film coated tablet contains:
Supplement Facts|
**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% |
INACTIVE INGREDIENT SECTION
OTHER INGREDIENTS
Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.
WARNINGS SECTION
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.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
One tablet daily, or as directed by a physician.
OVERDOSAGE SECTION
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.
HOW SUPPLIED SECTION
HOW SUPPLIED
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.
STORAGE AND HANDLING SECTION
STORAGE
Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F) [See USP controlled room temperature].
PRECAUTIONS SECTION
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.