SIDE EFFECTS: Sleepiness, trouble waking up, dizziness, excitation, headache, tiredness, loss of appetite, nausea, or vomiting may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, depression, hallucinations, thoughts of suicide, nightmares), slurred speech, staggering walk/clumsiness, double vision, memory problems. Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, or have prepared/eaten food, made phone calls, or had sex while not fully awake. Often these people do not remember these events. If you discover that you have done any of these things, tell your doctor right away. Drinking alcohol, taking other medications that cause drowsiness, or taking higher doses of butabarbital may increase your risk for this effect. Do not drink alcohol while using this medication. Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, slow heartbeat. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking butabarbital, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as phenobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain hormone problems (adrenal disease such as Addison's disease), liver problems, kidney problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal/family history of a certain blood disorder (porphyria). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. The liquid form of this product may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially drowsiness and dizziness. However, this drug can often cause excitement or confusion instead of drowsiness in older adults. Drowsiness, confusion, and dizziness can increase the risk of falling. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. Since birth control pills may not be effective if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. If you become pregnant while taking this medication, notify your doctor right away. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: darunavir, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine). Other medications can affect the removal of butabarbital from your body, which may affect how butabarbital works. Examples include disulfiram, phenytoin, valproic acid, St. John's wort, among others. This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include doxycycline, estrogens, griseofulvin, ranolazine, "blood thinners" such as warfarin, corticosteroids such as prednisone, calcium channel blockers such as felodipine/nimodipine, among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe tiredness/dizziness, inability to wake up, very slow breathing rate.