Quick answers
- What is Acetaminophen, caffeine, dihydrocodeine bitartrate used for?
- The FDA-approved label (Trezix, Proficient Rx LP, May 2, 2022) says: “TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Acetaminophen, caffeine, dihydrocodeine bitartrate have a boxed warning?
- Yes. The FDA label for Trezix has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Acetaminophen, caffeine, dihydrocodeine bitartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Acetaminophen, caffeine, dihydrocodeine bitartrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Acetaminophen, caffeine, dihydrocodeine bitartrate?
- 1 company lists prescription products of Acetaminophen, caffeine, dihydrocodeine bitartrate in the FDA NDC Directory, including Proficient Rx LP.
What Acetaminophen, caffeine, dihydrocodeine bitartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TREZIX™ (acetaminophen, caffeine, and dihydrocodeine bitartrate) capsulesare indicated for the relief of moderate to moderately severe pain.
— FDA label: Trezix, Proficient Rx LP, effective May 2, 2022. Read the full label on DailyMed →
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 →
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Trezix |
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.
- Proficient Rx LP1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA204785Key Therap · November 26, 2014
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
| RxCUI (RxNorm) | 1190201, 1596108 |
|---|---|
| SPL set ID of the quoted label | 45c3c2a1-6a89-471e-b6d4-5a4cd73b987a |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | ACETAMINOPHEN / CAFFEINE / DIHYDROCODEINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Trezix, Proficient Rx LP, effective May 2, 2022; 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 →