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

image description
(click image for full-size original)

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

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.