Naproxen / Pseudoephedrine
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)
- MUCINEX DS 12HR COLD, FEVER AND SINUS (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RECKITT BENCKISER LLC]
- NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS (NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [VESPYR BRANDS LLC]
- ALEVE-D SINUS AND COLD (NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE) TABLET [BAYER HEALTHCARE LLC.]
- ALEVE-D SINUS AND HEADACHE (NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [BAYER HEALTHCARE LLC.]
- LEADER ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]
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.