Clonidine Hydrochloride: Package Insert and Label Information (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0228-4241 -06

Clonidine Hydrochloride Extended-Release Tablets

0.1 mg

PHARMACIST: Dispense separate Patient Information leaflet to each patient.

60 Tablets

Rx Only

1
(click image for full-size original)

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-4241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
FERRIC OXIDE RED
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 241
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-4241-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203320 06/17/2015
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 02/2020 Actavis Pharma, Inc.

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