Se-Natal 19 (.beta.-carotene 1000 [iu] ascorbic acid 100 mg cholecalciferol 400 [iu] .alpha.-tocopherol acetate, dl- 30 mg thiamine 3 mg riboflavin 3 mg niacinamide 15 mg pyridoxine hydrochloride 20 mg folic acid 1 mg cyanocobalamin 12 ug calcium pantothenate 7 mg calcium carbonate 200 mg ferrous fumarate 29 mg zinc oxide 20 mg docusate sodium 25 mg) Dailymed
Generic: .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 is used for the treatment of Beriberi Pellagra Thiamine Deficiency Wernicke Encephalopathy Alcoholic Neuropathy Alzheimer Disease Anemia, Hemolytic Bronchopulmonary Dysplasia Dyskinesia, Drug-Induced Vitamin E Deficiency Anemia, Pernicious Diabetic Neuropathies Multiple Sclerosis Vitamin B 12 Deficiency Dermatitis, Atopic Diaper Rash Eczema Skin Neoplasms Sunburn Wounds and Injuries Cafe-au-Lait Spots Common Cold Hyperoxaluria Methemoglobinemia Scurvy Wounds, Penetrating Tyrosinemias Duodenal Ulcer Dyspepsia Esophagitis, Peptic Gastroesophageal Reflux Heartburn Gastrointestinal Hemorrhage Hypercalcemia Hypocalcemia Kidney Calculi Kidney Failure, Chronic Osteoporosis Stomach Ulcer Osteoporosis, Postmenopausal Hypophosphatemia Vitamin B Deficiency Seizures Vitamin B 6 Deficiency Drug-Related Side Effects and Adverse Reactions Cardiovascular Diseases Crohn Disease Hypoparathyroidism Lung Neoplasms Psoriasis Familial Hypophosphatemic Rickets Anemia, Megaloblastic Hemochromatosis Hemosiderosis Pregnancy Complications, Hematologic Anemia, Iron-Deficiency Anemia, Aplastic Folic Acid Deficiency Neural Tube Defects Constipation Intestinal Obstruction Nausea Vomiting Abdominal Pain Coronary Artery Disease Diarrhea Flatulence Flushing Hemorrhage Hypercholesterolemia Hypotension Liver Diseases Peptic Ulcer Hypertriglyceridemia Peripheral Vascular Diseases Riboflavin Deficiency
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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:
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 B​1​) 3 mg 214% Riboflavin (Vitamin B​2​) 3 mg 188% Niacin (as niacinamide) 15 mg 83% Vitamin B​6​ (as pyridoxine HCl) 20 mg 1000% Folate (folic acid) 1000 mcg 167% Vitamin B​12​ (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
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 SECTION
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. Do not chew tablet.
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
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 PharmaceuticalsManasquan, 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
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