Se-Natal 19 Tablets

Manufacturer
Seton Pharmaceuticals
Effective date
2025-02-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 21:26:29

Label at a glance#

ProductSe-Natal 19
Active ingredient.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, DOCUSATE SODIUM
Label structure17 sections

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

Vitamins & Minerals with Folic Acid

Rx Only

DESCRIPTION

DESCRIPTION SECTION

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 IU23%
Vitamin C (ascorbic acid)100 mg83%
Vitamin D (as cholecalciferol)10 mcg67%
Vitamin E (as dl-alpha tocoperol acetate)30 IU142%
Thiamine (Vitamin B​1​)3 mg214%
Riboflavin (Vitamin B​2​)3 mg188%
Niacin (as niacinamide)15 mg83%
Vitamin B​6​ (as pyridoxine HCl)20 mg1000%
Folate (folic acid)1000 mcg167%
Vitamin B​12​ (as cyanocobalamin)12 mcg 429%
Pantothenic Acid (as calcium pantothenate) 7 mg 100%
Calcium (as calcium carbonate)200 mg15%
Iron (as ferrous fumarate)29 mg107%
Zinc (as zinc oxide)20 mg 154%

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

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

INDICATIONS

INDICATIONS & USAGE SECTION

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

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. Do not chew tablet.

​HOW SUPPLIED

HOW SUPPLIED SECTION

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

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/NF with child-resistant closure.

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SPL UNCLASSIFIED SECTION

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 Pharmaceuticals
Manasquan, 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

PRINCIPAL DISPLAY PANEL - 100 tabletsPRINCIPAL DISPLAY PANEL - 100 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1313925alpha-tocopherol acetate 30 UNT / ascorbic acid 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / docusate sodium 25 MG / ferrous fumarate 29 MG / folic acid 1 MG / niacinamide 15 MG / pyridoxine hydrochloride 20 MG / riboflavin 3 MG / thiamine 3 MG / vitamin B12 0.012 MG / zinc oxide 20 MG Oral TabletSCD9
1313925alpha-tocopherol acetate 30 UNT / vit-C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vit-B6 hydrochloride 20 MG / riboflavin 3 MG / vit-B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vit-C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vit-B6 hydrochloride 20 MG / riboflavin 3 MG / vitamin B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vit-C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vitamin B6 hydrochloride 20 MG / riboflavin 3 MG / vit-B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vit-C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vitamin B6 hydrochloride 20 MG / riboflavin 3 MG / vitamin B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vit-B6 hydrochloride 20 MG / riboflavin 3 MG / vit-B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vit-B6 hydrochloride 20 MG / riboflavin 3 MG / vitamin B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vitamin B6 hydrochloride 20 MG / riboflavin 3 MG / vit-B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9
1313925alpha-tocopherol acetate 30 UNT / vitamin C 100 MG / beta carotene 1000 UNT / calcium carbonate 200 MG / calcium pantothenate 7 MG / cholecalciferol 400 UNT / DOSS sodium 25 MG / ferrous fumarate 29 MG / folate 1 MG / niacinamide 15 MG / vitamin B6 hydrochloride 20 MG / riboflavin 3 MG / vitamin B1 3 MG / vitamin B12 0.012 MG / ZNO 20 MG Oral TabletSY9

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13925-116-01Se-Natal 19100 in 1 BOTTLETABLET1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13925-116SE-NATAL 19 (.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 ) TABLET [SETON PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20250226_635104e6-6a53-4684-ac9a-7ac31b33083d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13925-116-01EA - Each13925-116f8a80b30-6ccc-4641-be3f-55847f3289bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, DL-ACTIVE INGREDIENTWR1WPI7EW82
.BETA.-CAROTENEACTIVE INGREDIENT01YAE03M7J2
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R2
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK2
CALCIUM PANTOTHENATEACTIVE INGREDIENT568ET80C3D2
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF412
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2042
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA02
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0Q2
FOLIC ACIDACTIVE INGREDIENT935E97BOY82
NIACINAMIDEACTIVE INGREDIENT25X51I8RD42
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV2
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR2
THIAMINEACTIVE INGREDIENTX66NSO3N352
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
.ALPHA.-TOCOPHEROL, DL-ACTIVE MOIETY7QWA1RIO012
.BETA.-CAROTENEACTIVE MOIETY01YAE03M7J2
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB2
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF412
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2042
DOCUSATEACTIVE MOIETYM7P27195AG2
FERROUS CATIONACTIVE MOIETYGW89581OWR2
FOLIC ACIDACTIVE MOIETY935E97BOY82
NIACINAMIDEACTIVE MOIETY25X51I8RD42
PANTOTHENIC ACIDACTIVE MOIETY19F5HK27372
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z2
RIBOFLAVINACTIVE MOIETYTLM2976OFR2
THIAMINE IONACTIVE MOIETY4ABT0J945J2
ZINC CATIONACTIVE MOIETY13S1S8SF372
ACACIAINACTIVE INGREDIENT5C5403N26O2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9902
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13925-11613925-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET / ORAL165 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 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.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 SODIUMSeton Pharmaceuticals635104e6-6a53-4684-ac9a-7ac31b33083d2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 13925-116-01
ndc (product): 13925-116
ndc11 (package): 13925011601
spl id: b6743f78-a3c4-452e-97c5-ab8e2af7f232
spl set id: 635104e6-6a53-4684-ac9a-7ac31b33083d

Reported adverse events (FAERS/openFDA)#

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