ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE

(a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen) Brand: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

What is the most significant information I must know about this medicine?

• You must not use this medicine if you have porphyria (a genetic enzyme mess that causes symptoms affecting the skin or nervous system).

• In rare cases, acetaminophen may reason a severe skin reaction. Stop taking this medication and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

• Medicines that contain codeine must not be given to a baby just after surgery to remove the tonsils or adenoids.

• Get abnormal medical help if a baby taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you can't wake the baby up from sleep.

What is this acetaminophen, butalbital, caffeine, and codeine?

• Codeine is an opioid pain medicine. An opioid is sometimes called a narcotic. Acetaminophen is a smaller potent pain reliever that increases the effects of codeine.

• Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

• Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

• The combination of acetaminophen, butalbital, caffeine, and codeine is used to treat tension headaches. This medication is not for treating headaches that come and go.

• Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking this medicine?

• You must not use this medication if you are allergic to acetaminophen, butalbital, caffeine, or codeine, or if you have porphyria (a genetic enzyme mess that causes symptoms affecting the skin or nervous system).

• In some people, codeine breaks down rapidly in the liver and reaches higher than usual levels in the body. This can reason dangerously slow breathing and may reason death, especially in a baby.

• Medicines that contain codeine must not be given to a baby just after surgery to remove the tonsils or adenoids.

• Butalbital and codeine may be habit forming. Never share this medication with other face, especially somebody with a history of drug abuse or addiction. Hold the medicine in a seat where others can't get to it.

• To create certain this medication is safety for you, speak your doctor if you have:

· liver malady, alcoholism, or if you drink more than 3 alcoholic beverages for day;

· asthma, COPD, sleep apnea, or another breathing disorders;

· curvature of the spine that affects breathing;

· kidney disease;

· a history of head injury or brain tumor;

· a thyroid disorder;

· blockage in your digestive tract (stomach or intestines);

· an enlarged prostate or urination problems;

· Addison's malady or another adrenal gland disorder;

· mental diseases; or

· a history of drug or alcohol addiction.

• FDA pregnancy category C. It is not known whether this medicine is deleterious to an unborn child, but it could reason breathing problems, seizures, or addiction/withdrawal symptoms in a newborn. Speak your doctor if you are pregnant or plan to become pregnant during treatment.

• This medicine can pass into breast milk and may harm a nursing child. The use of codeine by some nursing mothers may lead to life-threatening side effects in the child. Do not breast-feed while taking this medicine.

• Serious side effects may be more likely in older adults and those who are ill or debilitated.

How must I take this medicine?

• Follow all directions on your prescription label. Never take this medication in larger amounts, or for longer than predesigned. An overdose of acetaminophen can hurt your liver or reason death.

• Speak your doctor if the medication seems to stop working as well in relieving your pain.

• Do not stop using this medicine suddenly after regular use, or you could have unpleasant withdrawal symptoms. Conversation to your doctor about how to avoid withdrawal symptoms when stopping the medication.

• If you need surgery or medical trials, speak the surgeon or doctor onward of time that you are using this medicine.

• Store at room temperature away from moisture and heat.

• Hold track of the amount of medication used from every new bottle. Butalbital and codeine are drugs of abuse and you must be aware if anyone is using your medication improperly or without a prescription.

What happens if I miss a dose?

• Since this medication is taken as needed, you may not be on a dosing schedule. If you are taking the medicine regularly, take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medication can be fatal.

• The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

• Overdose symptoms may also include extreme drowsiness or insomnia, restless feeling, tremors, quick heart course, pinpoint pupils, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

What must I avoid while taking this medicine?

• Drinking alcohol can magnify dangerous side effects of butalbital or codeine.

• This medicine may reason blurred vision and may impair your thinking or reactions. Avoid driving or operating machinery before you know how the medicine will affect you.

• Ask a doctor or pharmacist till using any another cool, allergy, pain, or sleep medicine. Acetaminophen (sometimes abbreviated as APAP) is contained in much combination medicines. Taking determined commodity together can reason you to get too many acetaminophen which can lead to a fatal overdose. Check the label to see if a medication contains acetaminophen or APAP.

What are the possible side effects of this medicine?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• In rare cases, acetaminophen may reason a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medication and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you must never again take any medication that contains acetaminophen.

• Seek abnormal medical attention if a baby taking this medicine has any of the next life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or heavy to wake up; blue colored lips.

• Stop using this medicine and call your doctor at once if you have:

· a light-headed feeling, like you might pass out;

· shallow breathing, slow heart rate;

· quick or pounding heart course, feeling short of breath;

· confusion, hallucinations, unusual thoughts or behavior;

· muscle twitching, feelings of extreme happiness or sadness;

· light bruising or bleeding;

· few or no urinating; or

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• General side effects include:

· drowsiness, dizziness;

· feeling restless or anxious;

· mild nausea, vomiting, stomach pain;

· feeling "drunk."

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect acetaminophen, butalbital, caffeine, and codeine?

• This list is not complete. Another drugs may interact with acetaminophen, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Not all possible interactions are listed in this medicine manual.

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, butalbital, caffeine, and codeine.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.