ERGOCALCIFEROL- ergocalciferol liquid 
Virtus Pharmaceuticals

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Ergocalciferol
Oral Solution, USP

69543-234-60

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

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).

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.

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.

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
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)

Revised: 2/2016
Document Id: b9c5c7ae-5a33-4105-9252-ed09873335bb
Set id: 7dec2cd0-b4cf-45b7-924c-cbb003f5f8f8
Version: 2
Effective Time: 20160223
 
Virtus Pharmaceuticals