Label: 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 sodium tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 12, 2019

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  • SPL UNCLASSIFIED SECTION

    Vitamins & Minerals with Folic Acid

    Rx Only

  • 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 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

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

  • 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

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

  • 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.

  • 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.

  • ​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.

  • 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.

  • DOSAGE AND ADMINISTRATION

    One tablet daily, or as directed by a physician.

  • ​NOTICE

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

  • ​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

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

  • 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.

  • 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 tablets

  • INGREDIENTS AND APPEARANCE
    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 sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13925-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE1000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID7 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code TL019
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13925-116-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2009
    Labeler - Seton Pharmaceuticals (828898002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow Gold800695152REPACK(13925-116)