Possible Side Effects and Safety of Karbinal ER

What is the most important information I should know about Karbinal ER?

Use of Karbinal ER may result in decreased mental alertness with impaired mental or physical abilities.

The most common side effects of Karbinal ER include:

Karbinal ER is contraindicated in children younger than 2 years of age, and nursing mothers.
Karbinal ER may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Karbinal ER. Avoid concurrent use of Karbinal ER with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur.
Avoid use of Karbinal ER with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.) due to additive effects.
Karbinal ER is contraindicated in patients who are taking monoamine oxidase inhibitors (MAOI).

What are the possible side effects of Karbinal ER?

Use of Karbinal ER may result in decreased mental alertness with impaired mental or physical abilities.

The most frequent side effects include:

Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

For additional safety information, click here for Full Prescribing Information and discuss with your healthcare provider.

Keep Karbinal ER and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Karbinal ER is contraindicated in children younger than 2 years of age, and nursing mothers.
Karbinal ER may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Karbinal ER. Avoid concurrent use of Karbinal ER with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur.
Avoid use of Karbinal ER with alcohol and other CNS depressants (hypnotics sedatives, tranquilizers, etc.) due to additive effects.
Karbinal ER is contraindicated in patients who are taking monoamine oxidase inhibitors (MAOI).

Use of Karbinal ER may result in decreased mental alertness with impaired mental or physical abilities.

The most frequent side effects include:

Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

For additional safety information, click here for Full Prescribing Information and discuss with your healthcare provider.

Keep Karbinal ER and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.