Ergocalciferol (Page 2 of 2)

DOSAGE AND ADMINISTRATION

THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.

Vitamin D Resistant Rickets: 12,000 to 500,000 USP units daily.

Hypoparathyroidism: 50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six times per day.

DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.

Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.

HOW SUPPLIED

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP.

NDC 62135-439-90 Bottles of 90 Softgel Capsules
Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured by:

Swiss Caps AG

Kirchberg, Switzerland

Manufactured for:

Chartwell RX, LLC.

Congers, NY 10920

Revision: 02/2023

L71168

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Vitamin D Ergocalciferol Capsules, USP 1.25mg (50,000 USP Units) NDC-62135-439-90 — 90s Bottle Label

ERGOCALCIFEROL ergocalciferol capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-439 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 1.25 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN WATER SOYBEAN OIL

Product Characteristics Color green Score no score Shape OVAL Size 13mm Flavor Imprint Code A3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62135-439-90 90 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040833 04/30/2018

Labeler — Chartwell RX, LLC (079394054)

Revised: 02/2023 Chartwell RX, LLC