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Package Insert and Label Information: Fluoxetine

By TEVA Canada Limited | Last revised: 6 February 2011

FLUOXETINE- fluoxetine hydrochloride capsule
TEVA Canada Limited

Package/Label Principal Display Panel

Fluoxetine Capsules USP 20 mg Bulk Label
(click image for full-size original)

Fluoxetine Capsules USP 20 mg Bulk Label Text

NDC: 43806-648-00

FLUOXETINE CAPSULES USP, 20 mg

ITEM #: 50111-0648-99

ORACLE ITEM #: 72636-6200

Approximate Qty __________________ Capsules

FOR REPACKAGING ONLY

Store between 20 — 25 degree C

Protect from light

Handle with care

Manufactured in Canada by: TEVA CANADA LTD

For: USA

FLUOXETINE
fluoxetine capsule
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:43806-648
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
MAGNESIUM STEARATE
STARCH, CORN
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE, GREEN Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code PLIVA;648
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43806-648-00 37313 CAPSULE (CAPSULE) in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Drug for Further Processing 02/06/2011
Labeler — TEVA Canada Limited (201518008)

Revised: 02/2011 TEVA Canada Limited

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