Acetaminophen / 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)
- HEAD CONGESTION AND MUCUS (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]
- TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SELECT CONSUMER GROUP LLC]
- SEVERE SINUS CONGESTION RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]
- DAYTIME NIGHTTIME SINUS RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL) KIT [TARGET CORPORATION]
- SINUS CONGESTION AND PAIN RELIEF NON-DROWSY/DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]
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.