Ergocalciferol Oral Solution, USP

STATEMENT OF IDENTITY SECTION

69543-234-60

Vitamin D Supplement Drops8000 lU (0.2mg) Ergocalciferol per mL

HEALTH CLAIM SECTION

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 SECTION

Adequate intake (AI) (minimum daily intake) of vitamin D is needed to support calcium metabolism and bone health, particularly in the young and old.This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

KEEP THIS AND ALLMEDICATIONS OUT OF THEREACH OF CHILDREN.

HEALTH CLAIM SECTION

Manufactured for:Virtus Pharmaceuticals, LLCTampa, FL 336191-888-848-3593Made in USA

7274Rev. 09/15