Patients should be advised that adverse reactions common to all sulfonamide derivatives may occur, including anaphylaxis, fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia, leucopenia, pancytopenia, and agranulocytosis. If such reactions occur, the drug should be discontinued and appropriate therapy instituted.
Patients should be advised on the potential for anorexia, tachypnea, lethargy, coma, and death with the concomitant use of high-dose aspirin and DARANIDE® (dichlorphenamide tablets USP).
Dichlorphenamide may cause drowsiness/fatigue and myopia in some patients. Patients should be cautioned on the potential for impaired ability to drive and operate machinery.
Mfd. by: Taro Pharmaceutical Industries Ltd.
Haifa Bay, Israel 26110
Dist. by: TaroPharma a division of
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Daranide® and TaroPharma® are registered
trademarks of Taro Pharmaceuticals U.S.A., Inc.
Issued: February, 2012
PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label
(Dichlorphenamide Tablets USP) 50 mg
Keep this and all medications out
of the reach of children.
| DARANIDE |
|Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)|
|Taro Pharmaceutical Industries, Ltd.||600072078||MANUFACTURE (51672-4144)|
Revised: 02/2012 Taro Pharmaceuticals U.S.A., Inc.
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