Sertraline Hydrochloride (Page 8 of 8)

Medication Guide

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured by:
InvaGen Pharmaceuticals, Inc.
Hauppauge, NY 11788

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Rev: 05/
Rx only
Barcode: 214-05-2009


H.J. Harkins Company, Inc.
Nipomo, CA 93444

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-872(NDC:31722-213)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 25 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
D&C YELLOW NO. 10
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (Light Green) Score no score
Shape OVAL (modified, biconvex) Size 8mm
Flavor Imprint Code
Contains 212;IG
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-872-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:52959-872-60 60 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 12/18/2007
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-875(NDC:31722-212)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE 50 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FD&C BLUE NO. 2
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape OVAL (modified, biconvex) Size 10mm
Flavor Imprint Code
Contains 213;IG
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-875-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:52959-875-60 60 TABLET (TABLET) in 1 BOTTLE None
3 NDC:52959-875-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 12/18/2007
SERTRALINE HYDROCHLORIDE sertraline hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-876(NDC:31722-214)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE (SERTRALINE) SERTRALINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYDROXYPROPYL CELLULOSE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (Light Yellow) Score no score
Shape OVAL (modified, biconvex) Size 13mm
Flavor Imprint Code
Contains 214;IG
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-876-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:52959-876-60 60 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077397 12/18/2007
Labeler — H.J. Harkins Company Inc. (147681894)
Establishment
Name Address ID/FEI Operations
InvaGen Pharmceuticals Inc. 165104469 MANUFACTURE, ANALYSIS

Revised: 12/2011 H.J. Harkins Company Inc.

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