ions),
Believing things that are not true (delusions) and
Being suspicious (paranoia).
The symptoms of Bipolar Disorder include:
General symptoms of bipolar disorder include: extreme mood swings, along with other specific symptoms and behaviors. These mood swings, or "episodes," include manic (highs) and depressive (lows).
Common symptoms of a manic episode include: feeling extremely happy, being very irritable, restless, talking too fast and too much, and having more energy and needing less sleep than usual.
Common symptoms of a depressive episode include: feelings of sadness or emptiness, increased tearfulness, a loss of interest in activities you once enjoyed, loss of energy, difficulty concentrating or making decisions, feelings of worthlessness or guilt, changes in sleep or appetite and
Thoughts of death or suicide.
The symptoms of Major Depressive Disorder (MDD) include:
Feeling of sadness, emptiness and increase tearfulness,
Loss of interest in activities that you once enjoyed and loss of energy
Problems focusing and making decisions,
Feeling of worthlessness or guilt
Changes in sleep or eating patterns
Thoughts of death or suicide.
MDD symptoms last most of the day, nearly every day for at least two weeks, and interfere with daily life at home and at work
This Medication Guide has been approved by the U.S. Food and Drug Administration.
SEROQUEL XR is a registered trademark of the AstraZeneca group of companies
©AstraZeneca 2009
Distributed by:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
Rev. 12/0
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
SEROQUEL XR
quetiapine fumarate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0282
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM CITRATE
HYPROMELLOSE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
WATER
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (biconvex intagliated) Size 17mm
Flavor Imprint Code XR;200
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0282-39 10 BLISTER In 1 CARTON contains a BLISTER PACK
1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0310-0282-39)
2 0310-0282-50 500 TABLET In 1 BOTTLE None
3 0310-0282-94 4 TABLET In 1 BOTTLE None
4 0310-0282-60 60 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022047 01/08/2010
SEROQUEL XR
quetiapine fumarate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0283
Route of Administration ORAL DEA Schedule
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