Label: ONE VITE IRON SUPPLEMENT LIQUID- ferrous sulfate liquid

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated January 29, 2024

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Supplement Facts 
     Serving Size: 1 teaspoonful (5 mL)
    Servings per container: 94
     Amount per teaspoonful (5 mL) %Daily Value *  % Daily Value
     Calories 4
     Total Carbohydrate       1g <1%
     Total Sugars                 1g **
     includes 1g Added Sugars 2%
     Iron (elemental)
    (from ferrous sulfate)      44mg
     244%
     *% Daily Value tells you how much a nutrient in a serving
    of food contributes to a daily diet. 2,000 calories a day is
    used for general nutrition advice.
    **Daily Value not established

  • HEALTH CLAIM

    Each teaspoonful (5mL) contains 220mg Ferrous Sulfate, providing approximately 44mg of elemental iron.

    OTHER INGREDIENTS: Anhydrous citric acid, Dye FD&C yellow #6, Flavor cherry, Sodium Benzoate, Sucralose, Sucrose, Purified water.

  • SAFE HANDLING WARNING

    WARNING: Accidental overdose of iron containing supplements 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.

  • WARNINGS

    see boxed warning above.

  • PRECAUTIONS

    CAUTION: Do not exceed suggested serving size.

    The treatment of any anemic condition should be under the advice and supervision of a doctor. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two (2) hours of each other.
    This product may occasionally cause constipation, diarrhea, or may color stool black. It may cause gastrointestinal discomfort (such as nausea) which may be minimized by taking with meals.
    As with any supplement,
    if you are pregnant, nursing, taking medication, or under a doctor's care for any condition, ask a health professional before use.
    OTHER INFORMATION:
    Store at room temperature 15-30°C (59-86°F)

    Tamper-Evident: Do not use if foil seal over bottle opening is torn, broken or missing.
    Pharmacist:
    Dispense in a tight, light-resistant container with a child resistant cap as defined in the USP.

  • DOSAGE & ADMINISTRATION

    SUGGESTED USE: Adults and children 12 years and over, take one (1) teaspoonful daily with or after a meal as a dietary supplement, or as directed by your doctor.
    Children under 12, consult a doctor.
    Mix with water or juice to avoid temporary staining of teeth. Do not mix with milk or wine-based vehicles.

    DISTRIBUTED BY

    ATLANTIC BIOLOGICALS CORP

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    ONE VITE IRON SUPPLEMENT LIQUID 
    ferrous sulfate liquid
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:17856-0042(NDC:71399-0040)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION220 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:17856-0042-272 in 1 BOX, UNIT-DOSE
    1NHRIC:17856-0042-46.82 mL in 1 CUP, UNIT-DOSE
    2NHRIC:17856-0042-172 in 1 BOX, UNIT-DOSE
    2NHRIC:17856-0042-35 mL in 1 CUP, UNIT-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement08/04/2023
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    flavor
    Labeler - ATLANTIC BIOLOGICALS CORP (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0042)