NDC directory
What is butalbital and acetaminophen used for?
The FDA-approved uses of butalbital and acetaminophen, 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 and acetaminophen?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
The FDA label says: “Butalbital and Acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.”
Butalbital and Acetaminophen, tablet
Indications and Usage, quoted from the label by Larken Laboratories, Inc. (ANDA203484). Cross-references to other label sections are left out.
Butalbital and Acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Source: DailyMed label, set id 326c83fc-afed-45ad-9c87-f47968fa1d2a, version 17, effective October 15, 2025. NDC 68047-721, one of 10 listings for this product.
Questions
What is butalbital and acetaminophen used for?
The FDA label says: “Butalbital and Acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.”
What drug class is butalbital and acetaminophen?
FDA lists butalbital and acetaminophen in the Barbiturate 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.