Label: GESTYRA- ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 30, 2025

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  • DESCRIPTION

    Each Tablet Contains:

    Amount per Tablet

    Vitamin C (as ascorbic acid) ............................................................................... 125 mg

    Vitamin D (as cholecalciferol) ............................................................................. 12.5 mcg

    Thiamine (as hydrochloride) ............................................................................... 1.4 mg

    Vitamin B6 (as pyridoxal•S•phosphate) ...................................... ....................... 2.5 mg

    Folic Acid ............................................................................................................ 1 mg

    Vitamin B12 (as methylcobalamin)...................................................................... 1,000 mcg

    Calcium (from calcium carbonate) ...................................................................... 200 mg

    Iron (as ferrous gluconate) ................................................................................. 13 mg

    Iodine (as potassium iodide...............................................................................  150 mcg

    OTHER INGREDIENTS: Microcrystalline Cellulose, Magnesium Stearate, Silia, Glycerin, Vanilla Extract  

  • INDICATIONS AND USAGE

    Prenatal and Postnatal prescriptive Folic Acid

  • WARNINGS

    WARNING:  Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately. 
  • PRECAUTIONS

    Call your licensed medical practitioner about side effects.

  • DOSAGE AND ADMINISTRATION

    Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed practitioner.

  • HOW SUPPLIED

    Bottles of 30: 85477-922-30

    Storage

    KEEP THIS AND ALL MEDICATION OUR OF THE REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    Gestyra PDP
  • INGREDIENTS AND APPEARANCE
    GESTYRA 
    ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:85477-922
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL12.5 ug
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.4 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1000 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION13 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE0.15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85477-922-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/22/2025
    Labeler - Oncora Pharma LLC (119482542)