Codeine / Phenylephrine / Promethazine
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 for pain or cough in children <12 years; carries an FDA boxed warning. Also contraindicated in children <18 after tonsillectomy/adenoidectomy and in adolescents 12–18 who are obese or have OSA/respiratory compromise, due to ultra-rapid metabolism and fatal respiratory depression.
Source: FDA Drug Safety Communication 2017; codeine 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)
- PROMETHAZINE AND PHENYLEPHRINE HCL, AND CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS LLC]
- PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.]
- PROMETHAZINE VC WITH CODEINE (CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [DISPENSING SOLUTIONS, INC.]
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.