Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; risks from concomitant use with benzodiazepines or other CNS depressants

Contraindications

• All children younger than 12 years of age
• Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Known intolerance or hypersensitivity to acetaminophen, caffeine, butalbital, or codeine or to the components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules
• Porphyria

Adverse Reactions

• Drowsiness
• Lightheadedness
• Dizziness
• Sedation
• Shortness of breath
• Nausea
• Vomiting
• Abdominal pain
• Intoxicated feeling

General Guidance

Total daily dosage should not exceed 6 capsules

Pregnancy

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome
• Use with caution and only when benefits outweigh risks

Nursing Mothers

• Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are not recommended for use in nursing mothers

Pediatric Use

• Not recommended for children younger than 12 years of age
• Contraindicated for post-operative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy

Geriatric Use

• Use with caution in elderly patients due to increased sensitivity to the drug
• Monitor closely for signs of respiratory depression