It is very important that your doctor check your progress while you or your child are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.
Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Tension Headache
50 mg/300-325 mg/40 mg: 2 tablets or capsules PO q4hr; not to exceed 6 tablets or capsules/day
50 mg/500 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 6 tablets or capsules/day
50 mg/750 mg/40 mg: 1 tablet/capsule PO q4hr; not to exceed 5 tablets or capsules/day
15-30 mL solution PO q4hr; not to exceed 180 mL solution/day
Not to exceed 4 g/day of acetaminophen for any dosage form or regimen
Dosage Modifications
Renal impairment: Not studied; use caution and reduce dosing if necessary in severe renal impairment
Hepatic impairment: Not studied; use caution and reduce dosing if necessary in severe hepatic impairment
Dosing Considerations
Use of barbiturates increases the risk of chronic daily headache and drug induced hyperalgesia
American Migraine Prevalence and Prevention Study demonstrated that transformation is most likely to occur with 5 days of butalbital use per month (Lipton, RB et al. Headache. 2019 Sep; 59(8):1310-23)