Drug Reference

Acetaminophen / Guaifenesin

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Pediatric caution

Available as

162.5 MG325 MG · Oral Tablet325 MG · Oral Capsule
Multi-ingredient product
AcetaminophenGuaifenesin

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)

3 marketed products on record (RxNorm)

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.