Se-Natal 19 Chewable Tablets

Manufacturer
Seton Pharmaceuticals
Effective date
2025-03-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 21:27:28

Label at a glance#

ProductSe-Natal 19 Chewable
Active ingredientFOLIC ACID, .BETA.-CAROTENE, CALCIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE
Label structure17 sections

Indications and uses

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.

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].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

Rx Only

DESCRIPTION

DESCRIPTION SECTION

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 Size1 chewable tablet
​Each Tablet contains:

Vitamin A (as beta carotene)

1000 IU23%
Vitamin C (calcium ascorbate)100 mg83%
Vitamin D (as cholecalciferol)10 mcg67%
Vitamin E (as dl-alpha tocopherol acetate)30 IU142%
Thiamine (Vitamin B1)3 mg214%
Riboflavin (Vitamin B2​)3 mg188%
Niacin (as niacinamide)15 mg83%
Vitamin B6 (as pyridoxine HCl)20 mg1000%
Folate (folic acid)1000 mcg167%
Vitamin B12​ (as cyanocobalamin)12 mcg 429%
Pantothenic Aicd (as calcium pantothenate) 7 mg 100%
Calcium (as calcium carbonate)200 mg15%
Iron (as ferrous fumarate)29 mg 107%
Zinc (as zinc oxide) 20 mg 154%

​CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

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

PRECAUTIONS SECTION

GENERAL

SPL UNCLASSIFIED SECTION

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

​Folic Acid

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Safety and effectiveness in pediatric patients have not been established.

​Geriatric Use

SPL UNCLASSIFIED SECTION

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 SECTION

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

DRUG INTERACTIONS SECTION

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

OVERDOSAGE

OVERDOSAGE SECTION

Symptoms:

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

One tablet daily, or as directed by a physician.

NOTICE

SPL UNCLASSIFIED SECTION

Contact with moisture can discolor or erode the tablet.

HOW SUPPLIED

HOW SUPPLIED SECTION

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

STORAGE AND HANDLING SECTION

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

PHARMACIST

SPL UNCLASSIFIED SECTION

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

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

PRINCIPAL DISPLAY PANEL - 100 tabletsPRINCIPAL DISPLAY PANEL - 100 tablets

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13925-117-012024-02-01C16284748780-1d6a99b39-6a33-a426-e053-dadaa90af4c2Se-Natal 19 Chewable Tablets
13925-117-012022-01-28C16284748780-1d6a99b39-6a33-a426-e053-dadaa90af4c2Se-Natal 19 Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-117-01Se-Natal 19 Chewable100 in 1 BOTTLETABLET, CHEWABLE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-117SE-NATAL 19 CHEWABLE (VITAMINS AND MINERALS) TABLET, CHEWABLE [SETON PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20250315_a54dd642-8884-415a-a082-cd9fb544e400.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-117-01EA - Each13925-11726e64bae-b379-40fe-9547-06e9946b6fe412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW82
BETA CAROTENEACTIVE INGREDIENT01YAE03M7J2
CALCIUM ASCORBATEACTIVE INGREDIENT183E4W213W2
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK2
CALCIUM PANTOTHENATEACTIVE INGREDIENT568ET80C3D2
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF412
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2042
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0Q2
FOLIC ACIDACTIVE INGREDIENT935E97BOY82
NIACINAMIDEACTIVE INGREDIENT25X51I8RD42
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV2
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR2
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
.ALPHA.-TOCOPHEROL, DL-ACTIVE MOIETY7QWA1RIO012
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R2
BETA CAROTENEACTIVE MOIETY01YAE03M7J2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF412
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2042
FERROUS CATIONACTIVE MOIETYGW89581OWR2
FOLIC ACIDACTIVE MOIETY935E97BOY82
NIACINAMIDEACTIVE MOIETY25X51I8RD42
PANTOTHENIC ACIDACTIVE MOIETY19F5HK27372
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z2
RIBOFLAVINACTIVE MOIETYTLM2976OFR2
THIAMINE IONACTIVE MOIETY4ABT0J945J2
ZINC CATIONACTIVE MOIETY13S1S8SF372
ACACIAINACTIVE INGREDIENT5C5403N26O2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
ORANGE JUICEINACTIVE INGREDIENT5A9KE2L9L32
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
STEVIA REBAUDIUNA LEAFINACTIVE INGREDIENT6TC6NN08762
SUCROSEINACTIVE INGREDIENTC151H8M5542

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13925-11713925-117-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ORANGE JUICEORANGE JUICE5A9KE2L9L3SOLUTION / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ORANGE JUICEORANGE JUICE5A9KE2L9L3SOLUTION / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Se-Natal 19 ChewableVITAMINS AND MINERALSSeton Pharmaceuticalsa54dd642-8884-415a-a082-cd9fb544e4002025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 13925-117-01
ndc (product): 13925-117
ndc11 (package): 13925011701
spl id: b623b8b8-5503-4354-9bfd-4610257ceb87
spl set id: a54dd642-8884-415a-a082-cd9fb544e400

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.