Prescription medicine
Acetaminophen and butalbital Brand names: Allzital, Tencon
Acetaminophen and butalbital (Tencon) is a prescription medicine. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.571 per butalbital-acetaminophen 50-325 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule III
Check it at the source: the acetaminophen and butalbital FDA label on DailyMed (effective May 6, 2024, QUAGEN PHARMACEUTICALS LLC); every acetaminophen and butalbital label on DailyMed.
Highlights of the record
FDA label of May 6, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
HEPATOTOXICITY ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.
Used for
From the label: indications and usageButalbital and acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Forms and strengths
- 25 mg / 325 mg
- 50 mg / 300 mg
- 50 mg / 325 mg
- 300 mg / 50 mg
- 325 mg / 50 mg
- 325 mg / 25 mg
Tablet; capsule.
On the market
- Generic approvals
- 20 first October 19, 1984; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 10 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.571 per tablet Butalbital-acetaminophen 50-325 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 602 through July 30, 2026
What is acetaminophen and butalbital used for?
From the label: indications and usageButalbital 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.
FDA pharmacologic class: Barbiturate.
Source: FDA drug label (BUTALBITAL and ACETAMINOPHEN), QUAGEN PHARMACEUTICALS LLC, effective May 6, 2024 (SPL set 2eb09253-7f59-401e-afbc-70bb9600fedf), via openFDA; the full label on DailyMed
Is there a generic for acetaminophen and butalbital (Tencon)?
The FDA approved the first generic acetaminophen and butalbital on October 19, 1984. 20 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists acetaminophen and butalbital from 10 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for acetaminophen and butalbital (Tencon)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.571 per Butalbital-acetaminophen 50-325 mg tablet, down 8% from $0.624 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Butalbital-acetaminophen 50-325 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Butalbital-acetaminophen 50-300 mg tablet | Generic | $0.875 per tablet | $26.24 | -45% |
| Butalbital-acetaminophen 50-325 mg tablet | Generic | $0.571 per tablet | $17.13 | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the acetaminophen and butalbital label say about other medicines?
The acetaminophen and butalbital label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Chlordiazepoxide | drug interactions | Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression. |
Source: FDA drug label (BUTALBITAL and ACETAMINOPHEN), QUAGEN PHARMACEUTICALS LLC, effective May 6, 2024 (SPL set 2eb09253-7f59-401e-afbc-70bb9600fedf), via openFDA; the full label on DailyMed
What do FAERS reports show for acetaminophen and butalbital?
The FDA Adverse Event Reporting System holds 602 reports that list acetaminophen and butalbital among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 140 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other barbiturates
- the pharmacologic class, with prices and generics
- Acetaminophen and butalbital side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other