VITAMIN D (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 capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with ’194′ in white and contain clear light yellow oily liquid.

Bottles of 06 capsules (NDC: 63187-519-06)

Bottles of 08 capsules (NDC: 63187-519-08)

Bottles of 16 capsules (NDC: 63187-519-16)

Bottles of 30 capsules (NDC: 63187-519-30)

Bottles of 60 capsules (NDC: 63187-519-60)

Bottles of 90 capsules (NDC: 63187-519-90)

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Protect from light.

Manufactured By

Strides Arcolab Limited

Bangalore-560076, India

Distributed by:

Strides Pharma Inc

201 South Main Street, Suite 3

Lambertville, NJ 08530 USA

(06-2014)

Repackaged By:

Proficient Rx LP

Thousand Oaks, CA 91320

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle of 08 capsules

Proficient Rx LP

Rx only

NDC 63187-519-08

Vitamin D

(Ergocalciferol Capsules, USP)

1.25 mg*

(50,000 USP Units)

WARNING: DO NOT EXCEED

RECOMMENDED DOSAGE

08 Capsules

63187-519-08
(click image for full-size original)
VITAMIN D
ergocalciferol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-519(NDC:64380-737)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 1.25
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5
GELATIN, UNSPECIFIED
GLYCERIN
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
WATER
ETHYLENE GLYCOL MONOETHYL ETHER
SOYBEAN OIL
TITANIUM DIOXIDE
SHELLAC
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code 194
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-519-06 6 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:63187-519-08 8 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:63187-519-16 16 CAPSULE in 1 BOTTLE, PLASTIC None
4 NDC:63187-519-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
5 NDC:63187-519-60 60 CAPSULE in 1 BOTTLE, PLASTIC None
6 NDC:63187-519-90 90 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090455 05/16/2014
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079502574 REPACK (63187-519), RELABEL (63187-519)

Revised: 12/2018 Proficient Rx LP

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