Se-natal 19 Tablets

Se-natal 19 Tablets
SPL v9
SPL
SPL Set ID 635104e6-6a53-4684-ac9a-7ac31b33083d
Route
ORAL
Published
Effective Date 2025-02-24
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.beta.-carotene (1000 [iU]) Ascorbic Acid (100 mg) Cholecalciferol (400 [iU]) .alpha.-tocopherol, Dl- (30 mg) Thiamine Ion (3 mg) Riboflavin (15 mg) Niacinamide (20 mg) Pyridoxine (1 mg) Folic Acid (12 ug) Cyanocobalamin (7 mg) Pantothenic Acid (200 mg) Calcium Cation (29 mg) Ferrous Cation (25 mg) Zinc Cation Docusate
Inactive Ingredients
Acacia Croscarmellose Sodium Silicon Dioxide Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Polyvinyl Alcohol Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TL019 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2009-07-01

Description

Vitamins & Minerals with Folic Acid R x Only

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 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019", packaged in bottles of 100 tablets. Product Code: 13925-116-01.


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.

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 tablets for oral administration are supplied as white, coated, oblong tablets debossed "TL019", packaged in bottles of 100 tablets. Product Code: 13925-116-01.

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%

Section 42229-5

Vitamins & Minerals with Folic Acid

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].

Warnings

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

​notice

Contact with moisture can discolor or erode the tablet. Do not chew tablet.

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.

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.

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.

Precautions

​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

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.

​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.

Other Ingredients

Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.

​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.

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


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.

Section 42229-5 (42229-5)

Vitamins & Minerals with Folic Acid

Rx Only

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].

Warnings (WARNINGS)

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

​notice (​NOTICE)

Contact with moisture can discolor or erode the tablet. Do not chew tablet.

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.

Pharmacist (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.

Description (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%

Indications (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.

Precautions (PRECAUTIONS)

​symptoms: (​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 (​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.

​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.

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.

Other Ingredients (OTHER INGREDIENTS)

Acacia, Croscarmellose Sodium, Fumed Silica, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Stearic Acid, Talc and Titanium Dioxide.

​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.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

One tablet daily, or as directed by a physician.

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


Advanced Ingredient Data


Raw Label Data

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