Label: ERGOCALCIFEROL liquid

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated February 23, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • STATEMENT OF IDENTITY

    69543-234-60

    Vitamin D Supplement Drops
    8000 lU (0.2mg) Ergocalciferol per mL

  • HEALTH CLAIM

    Supplement Facts
    Serving Size: 400 IU
    Serving Per Container: 1200
    Amount Per Serving% Daily Value
    Vitamin D (ergocalciferol)400 IU100%

    Other Ingredients: Propylene Glycol

    The US RDA for Vitamin D is 400 IU for children and adults.

  • Description

    Each mL contains 8000 IU (0.2 mg) of ergocalciferol (Vitamin D2) dissolved in propylene glycol.

  • Directions for Use

    400 IU daily to be taken orally using the supplied pre-measured syringe. Submerge the tip of the syringe into the liquid, pull plunger back to bring the liquid to the 400 IU mark, and dispense into mouth.

    DO NOT FILL SYRINGE ENTIRELY.

  • Contraindications

    Contraindicated in people with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

  • Warning

    In case of accidental overdose contact a doctor or poison control center immediately.

    Hypersensitivity to vitamin D may be a causative factor in infants with idiopathic hypercalcemia. In these children, vitamin D must be strictly restricted.

  • Caution

    Adequate dietary calcium is necessary for response to vitamin D therapy.

  • Side Effects

    Metabolic side effects include hypercalcemia.

    You may report serious side effects by calling Virtus at 1-888-848-3593 or FDA at 1-800-FDA-1088

  • How Supplied

    Each 60 mL polycarbonate screw top bottle contains 60 mL ergocalciferol in a propylene glycol base (0.2 mg ergocalciferol per mL).

    Store at 20˚-25˚ C (68˚-77˚F); excursion permitted between 15˚-30˚ C (59˚-86˚ F).

  • HEALTH CLAIM

    Adequate intake (AI) (minimum daily intake) of vitamin D is needed to support calcium metabolism and bone health, particularly in the young and old.1


    1
    This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
  • SAFE HANDLING WARNING

    KEEP THIS AND ALL
    MEDICATIONS OUT OF THE
    REACH OF CHILDREN.

    Tamper Resistant Feature:
    Do NOT use if imprinted seal on cap is broken or missing.
  • HEALTH CLAIM

    Manufactured for:
    Virtus Pharmaceuticals, LLC
    Tampa, FL 33619
    1-888-848-3593
    Made in USA

    7274
    Rev. 09/15

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    VIRTUS
    PHARMACEUTICALS

    69543-234-60

    Ergocalciferol
    Oral Solution, USP

    Vitamin D Supplement Drops
    8000 IU (0.2mg) Ergocalciferol per mL

    60 mL (2 fl. oz.)

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ERGOCALCIFEROL 
    ergocalciferol liquid
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69543-234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC) Ergocalciferol0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69543-234-601 in 1 CARTON
    160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/25/2015
    Labeler - Virtus Pharmaceuticals (079659493)