SE-NATAL 19 CHEWABLE- vitamins and minerals tablet, chewable

Se-Natal 19 Chewable by

Drug Labeling and Warnings

Se-Natal 19 Chewable by is a Prescription medication manufactured, distributed, or labeled by Seton Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation

Rx Only

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 B​12​ 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 117-01

Rev. 03/18

SETON PHARMACEUTICALS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 13925-117-01

Se-Natal 19 Chewable Tablets

A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation

Rx Only

100 Tablets

SETON
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

SE-NATAL 19 CHEWABLE 
vitamins and minerals tablet, chewable

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 13925-117
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	1000 [iU]
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	15 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	20 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	7 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	29 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ORANGE JUICE (UNII: 5A9KE2L9L3)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	12mm
Flavor	ORANGE	Imprint Code	TL015
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13925-117-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2009

Labeler - Seton Pharmaceuticals (828898002)

Registrant - Seton Pharmaceuticals (828898002)

Establishment
Name	Address	ID/FEI	Business Operations
VIVA PHARMACEUTICAL INC.		253288898	manufacture(13925-117)