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What is butalbital, acetaminophen, caffeine and codeine used for?
The FDA-approved uses of butalbital, acetaminophen, caffeine and codeine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
Which 2027 plans near you dropped or restricted butalbital, acetaminophen, caffeine and codeine?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
The FDA label says: “Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.”
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate, capsule
Indications and Usage, quoted from the label by Hikma Pharmaceuticals USA Inc. (ANDA215138). Cross-references to other label sections are left out.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.
Limitations of Use
- Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy,, reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Source: DailyMed label, set id 6e0e8abc-512b-42f7-8323-434c589edecf, version 6, effective January 2, 2026. NDC 0054-0650, one of 7 listings for this product.
Questions
What is butalbital, acetaminophen, caffeine and codeine used for?
The FDA label says: “Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.”
What drug class is butalbital, acetaminophen, caffeine and codeine?
FDA lists butalbital, acetaminophen, caffeine and codeine in the Barbiturate and Central Nervous System Stimulant and Methylxanthine and Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Butalbital, Acetaminophen, Caffeine and Codeine
- Is Butalbital, Acetaminophen, Caffeine and Codeine a controlled substance?Schedule III
- Generic for Fioricet W/ CodeineFDA Orange Book
- Barbiturates listFDA drug class
- Central Nervous System Stimulants listFDA drug class
- Methylxanthines listFDA drug class
- Opioid Agonists listFDA drug class
- NDC 0054-0650Butalbital, Acetaminophen, Caffeine and Codeine NDC record
- NDC 0054-3000Butalbital, Acetaminophen, Caffeine and Codeine NDC record
- NDC 0591-2641Butalbital, Acetaminophen, Caffeine and Codeine NDC record
- Schedule III drugs listDEA schedule