Quick answers
- What is Butalbital and acetaminophen used for?
- The FDA-approved label (Tencon, El Dorado Distributors LLC, May 15, 2024) says: “Tencon (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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Butalbital and acetaminophen have a boxed warning?
- Yes. The FDA label for Tencon has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Butalbital and acetaminophen?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Butalbital and acetaminophen been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Butalbital and acetaminophen?
- 10 companies list prescription products of Butalbital and acetaminophen in the FDA NDC Directory, including Larken Laboratories, Inc., Amici Pharma, Inc. and Quagen Pharmaceuticals LLC.
What Butalbital and acetaminophen is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tencon (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.
— FDA label: Tencon, El Dorado Distributors LLC, effective May 15, 2024. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetaminophen 300 mg · butalbital 50 mg tablet | Generic | $0.8746 per tablet |
| acetaminophen 325 mg · butalbital 50 mg tablet | Generic | $0.5514 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Larken Laboratories, Inc.3 products
- Amici Pharma, Inc.3 products
- Quagen Pharmaceuticals LLC2 products
- Burel Pharmaceuticals, LLC2 products
- El Dorado Distributors LLC1 product
- Oceanside Pharmaceuticals1 product
- Aarkish Pharmaceuticals NJ Inc.1 product
- Dr. Reddy's Labratories Inc.1 product
- Par Health1 product
- Granules Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (9)
- ANDA089987Pharmobedient · October 26, 1992
- ANDA090956Lgm Pharma · August 23, 2011
- ANDA203484Pharmobedient · December 4, 2015
- ANDA207313DR Reddys Labs SA · December 27, 2017
- ANDA213115Granules · November 22, 2019
- ANDA214088Pharmazone · April 7, 2022
- ANDA214955Ne Rx Pharma · August 16, 2022
- ANDA214291Quagen · January 18, 2024
- ANDA214305Quagen · February 1, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tencon, El Dorado Distributors LLC, effective May 15, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →