"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
Codeine Sulfate Patient Information Including Side Effects
Generic Name: codeine (Pronunciation: KOE deen)
- What is codeine ?
- What are the possible side effects of codeine ?
- What is the most important information I should know about codeine ?
- What should I discuss with my healthcare provider before taking codeine ?
- How should I take codeine ?
- What happens if I miss a dose ?
- What happens if I overdose ?
- What should I avoid while taking codeine ?
- What other drugs will affect codeine ?
- Where can I get more information?
What is codeine ?
Codeine is an opioid pain medication. An opioid is sometimes called a narcotic.
Codeine is used to treat mild to moderately severe pain.
Codeine may also be used for purposes not listed in this medication guide.
Codeine Sulfate 15 mg-ROX
round, white, imprinted with 54 613
Codeine Sulfate 30 mg-ROX
round, white, imprinted with 54 783
Codeine Sulfate 60 mg-ROX
round, white, imprinted with 54 412
What are the possible side effects of codeine ?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.
Call your doctor at once if you have a serious side effect such as:
- slow heart rate, weak pulse, fainting, shallow breathing;
- feeling like you might pass out;
- confusion, agitation, hallucinations, unusual thoughts or behavior;
- feelings of extreme happiness or sadness;
- seizure (convulsions); or
- problems with urination.
Less serious side effects include:
- feeling dizzy or drowsy;
- nausea, vomiting, stomach pain;
- sweating; or
- mild itching or rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Codeine Sulfate (codeine) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about codeine ?
Codeine may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.
Never take codeine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how codeine will affect you.
Do not stop using codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using codeine.
Additional Codeine Sulfate Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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