Se-Natal 19 Prescribing Information
Package insert / product label
Generic name: vitamins and minerals
Dosage form: tablet
Drug classes: Iron products, Vitamin and mineral combinations
Medically reviewed by Drugs.com. Last updated on Jun 11, 2024.
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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.
Se-Natal 19 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% |
OTHER INGREDIENTS
Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.
Indications and Usage for Se-Natal 19
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.
Precautions
General
Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.
Adverse Reactions/Side Effects
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.
How is Se-Natal 19 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
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/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
SE-NATAL 19
.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 tablet |
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Labeler - Seton Pharmaceuticals (828898002) |
Registrant - Seton Pharmaceuticals (828898002) |
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