Acetaminophen / Tramadol
Opioids in combination with non-opioid analgesics
Fact box
- Therapeutic class
- Opioids in combination with non-opioid analgesics
Brand names
Available as
This medicine contains more than one active ingredient. To avoid attributing one component’s information to the whole product, structured label sections aren’t shown here — see the component pediatric notes below and the full combination label on DailyMed.
Pediatric use
Contraindicated in children <12 years and for post-tonsillectomy/adenoidectomy pain in those <18; boxed warning for life-threatening respiratory depression in ultra-rapid metabolizers.
Source: FDA Drug Safety Communication 2017; tramadol prescribing information (boxed warning).
⚑ About half of pediatric medication use is off-label and not described in FDA labels — absence of pediatric information does not mean a medicine is unused or unsafe in children. Confirm with your clinician.
Current FDA labels (DailyMed)
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [BRYANT RANCH PREPACK]
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]
- TRAMADOL/APAP TABLET [DIRECT_RX]
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET, FILM COATED [BRYANT RANCH PREPACK]
Authoritative sources
Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.