Ergocalciferol by Virtus Pharmaceuticals ERGOCALCIFEROL liquid

Ergocalciferol by

Drug Labeling and Warnings

Ergocalciferol by is a Other medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 IU	100%

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.)

INGREDIENTS AND APPEARANCE

ERGOCALCIFEROL 
ergocalciferol liquid

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:69543-234
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC)	Ergocalciferol	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69543-234-60	1 in 1 CARTON
1		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		08/25/2015

Labeler - Virtus Pharmaceuticals (079659493)