Yes

Analgesic, Combination (Narcotic); Barbiturate

Mild to moderate pain when sedation is needed

C-III

C/D (if used for prolonged periods or in high doses at term)

Hypersensitivity to butalbital, codeine, aspirin, or any component; opium derivatives; patients with a hemorrhagic diathesis (eg, hemophilia, hypoprothrombinemia, von Willebrand disease, the thrombocytopenias, thrombasthenia, and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency, and severe liver damage); patients with peptic ulcer or other serious GI lesions; patients with porphyria; pregnancy (if used for prolonged periods or in high doses at term)

Habit-forming, potentially abusable; patients on anticoagulant therapy

>10%:

Central nervous system: Dizziness, lightheadedness, drowsiness

Gastrointestinal: Nausea, heartburn, stomach pains, dyspepsia, epigastric discomfort

1% to 10%:

Central nervous system: Confusion, mental depression, unusual excitement, nervousness, faint feeling, insomnia, nightmares, intoxicated feeling

Dermatologic: Rash

Gastrointestinal: Constipation, GI ulceration

<1% (Limited to important or life-threatening symptoms): Tachycardia, chest pain, palpitations, syncope, hallucinations, nervousness, jitters, exfoliative dermatitis, Stevens-Johnson syndrome, agranulocytosis, megaloblastic anemia, thrombocytopenia, occult bleeding, prolongation of bleeding time, leukopenia, iron deficiency anemia, hepatotoxicity, thrombophlebitis, impaired renal function, respiratory depression, bronchospasm, epistaxis, allergic reaction

Symptoms of overdose include unsteady gait, slurred speech, confusion, respiratory depression, hypotension, and coma. Opioid symptoms may be reversed by naloxone, 2 mg I.V., with repeated doses as necessary up to a total of 10 mg. Barbiturate treatment is symptomatic and supportive.

Adults: Oral: 1-2 capsules every 4 hours as needed for pain; up to 6/day

No information available to require special precautions

<1%: Dry mouth

If self-administered, use exactly as directed (do not increase dose or frequency); may cause physical and/or psychological dependence. Take with food or milk. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). May cause dizziness, lightheadedness, confusion, or drowsiness (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); heartburn or epigastric discomfort (frequent mouth care, frequent sips of fluids, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, or dietary fruit and fiber may help - if constipation remains an unresolved problem, consult prescriber about use of stool softeners). Report chest pain or palpitations; persistent dizziness; confusion, nightmares, excitation, or changes in mentation; shortness of breath or difficulty breathing; skin rash, unusual bleeding or bruising; or unusual fatigue and weakness. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms

Capsule: Butalbital 50 mg, caffeine 40 mg, aspirin 325 mg and codeine phosphate 30 mg