DARANIDE (Page 2 of 2)

17 PATIENT COUNSELING INFORMATION

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

NDC 51672-4144-1
100 Tablets

Daranide®
(Dichlorphenamide Tablets USP) 50 mg

Keep this and all medications out
of the reach of children.
Rx only

PRINCIPAL DISPLAY PANEL -- 100 Tablet  Bottle Label
(click image for full-size original)
DARANIDE
dichlorphenamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4144
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
dichlorphenamide (dichlorphenamide) dichlorphenamide 50 mg
Inactive Ingredients
Ingredient Name Strength
D&C yellow no. 10
aluminum oxide
lactose monohydrate
magnesium stearate
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code TARO;D;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4144-6 30 TABLET in 1 BOTTLE None
2 NDC:51672-4144-1 100 TABLET in 1 BOTTLE None
3 NDC:51672-4144-3 1000 TABLET in 1 BOTTLE None
4 NDC:51672-4144-0 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (51672-4144-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011366 03/16/2012
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE (51672-4144)

Revised: 02/2012 Taro Pharmaceuticals U.S.A., Inc.

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