FDA label
What is Ascomp with Codeine used for?
Ascomp with Codeine contains butalbital, aspirin, caffeine and codeine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “ASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate.”
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Ascomp with Codeine, capsule
Indications and Usage, quoted from the label by Breckenridge Pharmaceutical, Inc. (ANDA075231). Cross-references to other label sections are left out.
ASCOMP with Codeine is 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 ASCOMP with Codeine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
ASCOMP with Codeine should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Source: DailyMed label, set id 243a6aea-0f48-42a9-a85e-ff247ab94336, version 13, effective February 9, 2026. NDC 51991-074, one of 2 listings for this product.
Questions
What is Ascomp with Codeine used for?
The FDA label says: “ASCOMP with Codeine is 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 Ascomp with Codeine?
FDA lists butalbital, aspirin, caffeine and codeine in the Barbiturate and Central Nervous System Stimulant and Methylxanthine and Nonsteroidal Anti-inflammatory Drug and Opioid Agonist and Platelet Aggregation Inhibitor 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 Ascomp with Codeine
- Is Ascomp with Codeine a controlled substance?Schedule III
- What is Butalbital, Aspirin, Caffeine and Codeine used for?FDA label uses
- Is Butalbital, Aspirin, Caffeine and Codeine a controlled substance?Schedule III
- Generic for Fiorinal W/codeineFDA Orange Book
- Barbiturates listFDA drug class
- Central Nervous System Stimulants listFDA drug class
- Methylxanthines listFDA drug class
- Nonsteroidal Anti-inflammatory Drugs listFDA drug class
- Opioid Agonists listFDA drug class
- Platelet Aggregation Inhibitors listFDA drug class
- NDC 51991-074Ascomp with Codeine NDC record
- NDC 79739-6094Ascomp with Codeine NDC record
- Schedule III drugs listDEA schedule