Label: BUTALBITAL/ACETAMINOPHEN/CAFFEINE capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 31, 2024

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  • Description
    Butalbital, Acetaminophen and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients ...
  • Clinical Pharmacology
    This combination drug product is intended as a treatment for tension headache . It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays ...
  • Indications and Usage
    Butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and ...
  • Contraindications
    This product is contraindicated under the following conditions: -Hypersensitivity or intolerance to any component of this product - -Patients with porphyria.
  • Warnings and Precautions
    Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended. Hepatotoxicity - Acetaminophen has been associated with cases of ...
  • Adverse Reactions
    Frequently Observed - The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and ...
  • Drug Abuse and Dependence
    Abuse and Dependence - Butalbital - Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high ...
  • Overdosage
    Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the ...
  • Dosage and Administration
    One or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical ...
  • How Supplied
    Butalbital, Acetaminophen , and Caffeine Capsules USP , 50 mg /300 mg/40 mg - Each butalbital, acetaminophen and caffeine capsule contain butalbital 50 mg, acetaminophen 300 mg and caffeine 40 ...
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