PAROXETINE (Page 18 of 18)

PRINCIPAL DISPLAY PANEL — 20 mg -30 count

label
(click image for full-size original)

PAROXETINE
paroxetine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-248(NDC:60505-0083)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE ANHYDROUS (PAROXETINE) PAROXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code APO;083
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-248-71 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:12634-248-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075356 09/08/2003
Labeler — Apotheca Inc. (051457844)
Establishment
Name Address ID/FEI Operations
Apotheca Inc. 051457844 repack (12634-248), relabel (12634-248)

Revised: 12/2015 Apotheca Inc.

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