What the FDA labels say about taking them together
Acetaminophen/benzhydrocodone and hydrocodone
Acetaminophen/benzhydrocodone's FDA label of January 7, 2025 names hydrocodone in its boxed warning section; the hydrocodone label PlainMeds reads does not name acetaminophen/benzhydrocodone. The acetaminophen/benzhydrocodone label: “The concomitant use of APADAZ and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. …”
Check it at the source: the acetaminophen/benzhydrocodone FDA label on DailyMed (effective January 7, 2025, Zevra Therapeutics, Inc.); the hydrocodone FDA label on DailyMed (effective May 29, 2026).
What does the acetaminophen/benzhydrocodone label say about hydrocodone?
Acetaminophen/benzhydrocodone label, boxed warningAccidental Ingestion Accidental ingestion of even one dose of APADAZ, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions ( 5.2 )].
Acetaminophen/benzhydrocodone label, contraindicationsCONTRAINDICATIONS APADAZ is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions ( 5.3 )] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions ( 5.8 )] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions ( 5.14 )] Hypersensitivity to hydrocodone or acetaminophen, or any other component of this product (e.g., anaphylaxis) [see Warnings and Precautions ( 5.13 ), Adverse Reactions ( 6 )] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative …
Acetaminophen/benzhydrocodone label, drug interactionsCYP3A4 and 2D6 Inhibitors Clinical Impact: The concomitant use of APADAZ and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of APADAZ and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of APADAZ … Intervention: If concomitant use is necessary, consider dosage reduction of APADAZ until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation at. …
Acetaminophen/benzhydrocodone label, warnings and precautionsAccidental ingestion of even one dose of APADAZ, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone.
Source: FDA drug label (APADAZ), Zevra Therapeutics, Inc., effective January 7, 2025 (SPL set 0590d4e5-7107-4015-a6a8-deac14265aa2), via openFDA; the full label on DailyMed
What does the hydrocodone label say about acetaminophen/benzhydrocodone?
Hydrocodone's label (effective May 29, 2026) does not name acetaminophen/benzhydrocodone in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (Hysingla ER), Knoa Pharma LLC, effective May 29, 2026 (SPL set b7d23ac2-e776-9f62-3290-c64c2d6eb353), via openFDA; the full label on DailyMed
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Acetaminophen/benzhydrocodone | Hydrocodone | |
|---|---|---|
| Labeled for | Pain | Pain |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | n/a | $7.95 per capsule 15 mg capsule |
| Shortage now | No current entry | No current entry |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once