se-natal 19 chewable tablets

se-natal 19 chewable tablets
SPL v9
SPL
SPL Set ID a54dd642-8884-415a-a082-cd9fb544e400
Route
oral
Published
Effective Date 2025-03-12
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
folic acid (1 mg) .beta.-carotene (1000 [iU]) ascorbic acid (100 mg) cholecalciferol (400 [iU]) .alpha.-tocopherol, dl- (30 [iU]) riboflavin (3 mg) niacinamide (15 mg) pyridoxine (20 mg) cyanocobalamin (12 ug) pantothenic acid (7 mg) calcium cation (200 mg) ferrous cation (29 mg) zinc cation
Inactive Ingredients
acacia silicon dioxide magnesium stearate orange juice stearic acid stevia rebaudiuna leaf sucrose

Identifiers & Packaging

Pill Appearance
Imprint: TL015 Shape: round Color: brown Size: 12 mm Score: 1
Marketing Status
unapproved drug other active Since 2009-07-01

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.

Dosage and Administration

One tablet daily, or as directed by a physician.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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

Description

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


Medication Information

Recent Major Changes

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.

Warnings

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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.

Dosage and Administration

One tablet daily, or as directed by a physician.

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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

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%

Notice

Contact with moisture can discolor or erode the tablet.

Section 42229-5

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

Rx Only

General

Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.

Storage

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)[See USP controlled room temperature].

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.

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 640138

Rev. 03/24

SETON PHARMACEUTICALS

Precautions

​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.

​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.

​pediatric Use

Safety and effectiveness in pediatric patients have not been established.

​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.

​other Ingredients

Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.

​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.

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


Structured Label Content

Recent Major Changes (34066-1)

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.

Warnings (WARNINGS)

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Indications and Usage (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.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

One tablet daily, or as directed by a physician.

Contraindications (CONTRAINDICATIONS)

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Drug Interactions (DRUG INTERACTIONS)

Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.

How Supplied (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

Description (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%

Notice (NOTICE)

Contact with moisture can discolor or erode the tablet.

Section 42229-5 (42229-5)

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

Rx Only

General (GENERAL)

Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear.

Storage (STORAGE)

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F)[See USP controlled room temperature].

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.

Pharmacist (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 640138

Rev. 03/24

SETON PHARMACEUTICALS

Precautions (PRECAUTIONS)

​folic Acid (​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.

​geriatric Use (​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.

​pediatric Use (​Pediatric Use)

Safety and effectiveness in pediatric patients have not been established.

​adverse Reactions (​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.

​other Ingredients (​OTHER INGREDIENTS)

Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose.

​clinical Pharmacology (​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.

Package Label.principal Display Panel (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


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