Colchicine (Page 10 of 10)

PRINCIPAL DISPLAY PANEL – 0.6 mg

NDC 0378-1086-93

Colchicine
Tablets, USP
0.6 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 30 Tablets

Each film-coated tablet contains:
Colchicine, USP 0.6 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Protect from light.

Usual Dosage: See accompanying
prescribing information.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Mylan.com

RM1086H

Colchicine Tablets 0.6 mg Bottle Label
(click image for full-size original)
COLCHICINE colchicine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-1086
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COLCHICINE (COLCHICINE) COLCHICINE 0.6 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color RED Score 2 pieces
Shape OVAL Size 8mm
Flavor Imprint Code M;CC;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-1086-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-1086-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209470 11/25/2019
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 08/2020 Mylan Pharmaceuticals Inc.

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