TYLENOL #3
Combination product
Pronunciation: a-set-a-MEE-noe-fen and KOE-deen
Combination of Acetaminophen and Codeine.
Each component keeps its own pharmacology page; the combination itself adds no new mechanism.
Components (2)
FDA label
Read the full label on DailyMed ↗
BOXED WARNING Opioid addiction/abuse/misuse; life-threatening respiratory depression; accidental ingestion (fatal in children); NOWS; risk with benzodiazepines/CNS depressants; ultra-rapid CYP2D6 metabolizers; hepatotoxicity (acetaminophen); REMS.
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Mild to moderate pain (opioid-appropriate) | Adults | 300–600 mg acetaminophen + 15–60 mg codeine q4h PRN | Codeine 360 mg/day; acetaminophen 4,000 mg/day |
Renal Undefined
Hepatic Undefined
q4h PRN dosing
Instructions
- Use lowest effective dose for shortest duration
- Taper gradually to discontinue in physically dependent patients; do not stop abruptly
Available strengths
- tab 300/15, 300/30, 300/60 mg
- sol 120/12 mg/5 mL
Contraindications
- Children <12 yr; post-op in children <18 yr after tonsillectomy/adenoidectomy
- Significant respiratory depression
- Acute or severe bronchial asthma in unmonitored setting or absent resuscitative equipment
- Concurrent MAOIs or use within 14 days
- Known/suspected GI obstruction, including paralytic ileus
Cautions
- Respiratory depression
- Addiction/abuse/misuse
- Adrenal insufficiency
- Severe hypotension
- Hepatotoxicity (acetaminophen)
- Risk in ultra-rapid CYP2D6 metabolizers
Adverse reactions
- Drowsiness, dizziness, sedation, lightheadedness
- Nausea, vomiting, constipation, sweating
- Respiratory depression (serious)
Pregnancy Prolonged use may cause NOWS; codeine in ultra-rapid metabolizers risks infant harm.
Lactation Not recommended; morphine (codeine metabolite) in breast milk risks infant respiratory depression, esp. in ultra-rapid metabolizers.
Cost
TYLENOL #3
What pharmacies pay · NADAC 9/30/26
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 300/15 mg | tab | per unit | $0.27/ea | not offered |
| 300/30 mg | tab | per unit | $0.26/ea | not offered |
| 300/60 mg | tab | per unit | $0.39/ea | not offered |
Other forms: Codeine (in TYLENOL #3)
Clinical profile
Defining liabilityRespiratory depression, variable codeine activation and acetaminophen hepatotoxicity
Part D rank #220.
Self-check
- Which acetaminophen–codeine component carries hepatotoxicity risk?
Acetaminophen. - Which codeine metabolism pattern is boxed?
Ultra-rapid CYP2D6 metabolism.