Ibuprofen / 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)
- ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]
- SUDAFED PE HEAD CONGESTION PLUS PAIN (IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]
- EQUALINE CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]
- ADVIL SINUS CONGESTION AND PAIN RELIEF (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]
- ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SELECT 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.