Drug Reference

Acetaminophen / Dextromethorphan / Doxylamine / Phenylephrine

Pediatric caution

Available as

325 MG · Oral Capsule21.7 MG/ML · Oral Solution650 MG · Powder250 MG · Oral Tablet325 MG · Oral Tablet325 MG · Powder43.3 MG/ML · Oral Solution

Multi-ingredient product

AcetaminophenDextromethorphanDoxylaminePhenylephrine

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

Pediatric caution

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)

8 marketed products on record (RxNorm)

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.