MedPath

Se-Natal 19

Se-Natal 19 Tablets

Approved
Approval ID

635104e6-6a53-4684-ac9a-7ac31b33083d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 12, 2024

Manufacturers
FDA

Seton Pharmaceuticals

DUNS: 828898002

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

.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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code13925-116
Product Classification
G
Generic Name
.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
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2019
FDA Product Classification

INGREDIENTS (26)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
.BETA.-CAROTENEActive
Quantity: 1000 [iU] in 1 1
Code: 01YAE03M7J
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 1
Code: 1C6V77QF41
Classification: ACTIB
RIBOFLAVINActive
Quantity: 3 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
THIAMINEActive
Quantity: 3 mg in 1 1
Code: X66NSO3N35
Classification: ACTIB
NIACINAMIDEActive
Quantity: 15 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 12 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 7 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
CALCIUM CARBONATEActive
Quantity: 200 mg in 1 1
Code: H0G9379FGK
Classification: ACTIM
FERROUS FUMARATEActive
Quantity: 29 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
ZINC OXIDEActive
Quantity: 20 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIM
DOCUSATE SODIUMActive
Quantity: 25 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 30 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/12/2019

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 tablets](/dailymed/image.cfm?name=bottle- label.jpg&id=770577)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2019

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.

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 1/1/2019

CONTRAINDICATIONS

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 1/1/2019

​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 SECTION

LOINC: 34073-7Updated: 1/1/2019

DRUG INTERACTIONS

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 1/1/2019

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

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/1/2019

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%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2019

OTHER INGREDIENTS

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

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2019

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2019

DOSAGE AND ADMINISTRATION

One tablet daily, or as directed by a physician.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 1/1/2019

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.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 1/1/2019

​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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/1/2019

STORAGE

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

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 1/1/2019

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.

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Se-Natal 19 - FDA Drug Approval Details