Acetaminophen / Dextromethorphan / Guaifenesin / Phenylephrine
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
OTC cough-and-cold products are not recommended for children <4 years (FDA) / <6 years (AAP) due to lack of efficacy and risk of serious adverse effects.
Source: FDA OTC cough/cold advisory; AAP guidance.
⚑ 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)
- COMPLETE COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [BELMORA LLC]
- COLD AND FLU RELIEF SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WINCO FOODS, LLC]
- MUCINEX FAST-MAX KICKSTART SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]
- VICKS DAYQUIL AND VICKS NYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
- VICKS DAYQUIL SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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.