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butalbital/acetaminophen - oral, Phrenilin (cont.)

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen or butalbital; or to other barbiturates (e.g., phenobarbital); or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, abdominal/intestinal problems.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Before having surgery, tell your doctor or dentist that you are using this medication.This product contains acetaminophen, which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information.Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.This drug should not be used with the following medication because very serious interactions may occur: sodium oxybate.If you are currently using the medication listed above, tell your doctor or pharmacist before starting butalbital/acetaminophen.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-seizure drugs (e.g., carbamazepine, phenytoin), drugs affecting liver enzymes that remove this medication from your body (such as disulfiram, valproic acid, MAO inhibitors including furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), isoniazid, methoxyflurane, phenothiazines (e.g., chlorpromazine).This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include "blood thinners" (e.g., warfarin), cyclosporine, corticosteroids such as prednisone, estrogen, felodipine, metronidazole, quinidine, certain beta blockers such as metoprolol, theophylline, doxycycline.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone).Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.Acetaminophen is an ingredient in many nonprescription products and in some combination prescription medications. Read the labels carefully before taking other pain relievers, fever reducers, or cold products to see if they also contain acetaminophen. Consult your pharmacist if you are uncertain whether your other prescription or nonprescription products contain acetaminophen. (See also adult maximum daily dose information in Side Effects section.)This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. Ask your doctor or pharmacist for details, and discuss whether you should use additional reliable birth control methods while taking any of these drugs.This medication may interfere with certain laboratory tests (including urine 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.



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