Acetaminophen/codeine
استامینوفن کدئین
🧠 Nervous SystemOpioid combination analgesic
Market / country: 🇺🇸 USA
Tylenol with Codeine (US)
🧮 Dose calculator
Mild to moderate pain · Regimen source: FDA APAP-codeine · Dosage and Administration
- • 300–600 mg acetaminophen + 30–60 mg codeine every 4 h; lowest effective dose. Acetaminophen max 4 g/day from all sources. FDA APAP-codeine · Dosage and Administration
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Contraindicated under 12 (fatal respiratory depression); after tonsillectomy under 18. FDA APAP-codeine · Contraindications
- ⚠️ Boxed warning: addiction, respiratory depression, ultra-rapid codeine metabolism, acetaminophen hepatotoxicity, benzodiazepine interaction. FDA APAP-codeine · Boxed Warning
Formulations
- Acetaminophen 300 mg + codeine 15 mg — tablet 🇺🇸 USA FDA APAP-codeine · How Supplied
- Acetaminophen 300 mg + codeine 30 mg — tablet 🇺🇸 USA FDA APAP-codeine · How Supplied
- Acetaminophen 300 mg + codeine 60 mg — tablet 🇺🇸 USA FDA APAP-codeine · How Supplied
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA APAP-codeine · Boxed Warning
“Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA APAP-codeine · Nursing Mothers
“Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with acetaminophen and codeine phosphate tablets (see WARNINGS ).”
- 👶 ChildrenContraindicated
Label: contraindicated in children below a stated age. FDA APAP-codeine · CONTRAINDICATIONS
“Acetaminophen and codeine phosphate tablets are contraindicated for: • All children younger than 12 years of age (see WARNINGS ) • Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see WARNINGS ).”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA APAP-codeine · Geriatric Use
“In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA211610
- DailyMed (FDA label)FDA APAP-codeine
- MedlinePlus (NIH)AcetaminophenAcetaminophen Injection
- WHO ATC/DDDN02AJ06
- Darooyab (Iran)Acetaminophen-Codeine
🇮🇷 Registered in Iran Darooyab · G-4643/Acetaminophen-Codeine
Dosage forms with Iranian generic codes, per Darooyab.
- 08440 · ACETAMINOPHEN CODEINE (300+10)MG TAB · قرص استامینوفن کدئین (۳۰۰ + ۱۰) میلیگرم
- 02243 · ACETAMINOPHEN CODEINE (300+20) TAB · قرص استامینوفن کدئین (۳۰۰ + ۲۰)
- 07716 · ACETAMINOPHEN CODEINE (500+30) MG TAB · قرص استامینوفن کدئین (۵۰۰ + ۳۰) میلیگرم
- 00010 · ACETAMINOPHEN CODEINE (500+8) TAB · قرص استامینوفن کدئین (۵۰۰ + ۸)
- 18838 · ACETAMINOPHEN CODEINE 300/10MG SOFT GEL CAP · کپسول نرم استامینوفن کدئین ۳۰۰ / ۱۰ میلیگرم
- 02404 · ACETAMINOPHEN CODEINE EFF TAB · قرص جوشان استامینوفن کدئین
- 52500 · ACETAMINOPHEN / CODEINE PHOSPHATE CAPSULE, LIQUID FILLED ORAL 300 mg/20 mg · کپسول استامینوفن / کدئین فسفات پرشده ۳۰۰ میلیگرم / ۲۰ میلیگرم
- 52312 · ACETAMINOPHEN / CODEINE PHOSPHATE TABLET ORAL 300 mg/10 mg · قرص استامینوفن / کدئین فسفات ۳۰۰ میلیگرم / ۱۰ میلیگرم
- 52922 · ACETAMINOPHEN / CODEINE PHOSPHATE TABLET ORAL 500 mg/8 mg · قرص استامینوفن / کدئین فسفات ۵۰۰ میلیگرم / ۸ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA APAP-codeine · Boxed WarningFDA APAP-codeine · How SuppliedFDA APAP-codeine · Dosage and AdministrationFDA APAP-codeine · ContraindicationsFDA APAP-codeine · Nursing MothersFDA APAP-codeine · CONTRAINDICATIONSFDA APAP-codeine · Geriatric UseFDA APAP-codeine · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4643/Acetaminophen-Codeine
- Clinical review⚠ Unverified