Drug Reference

Guaifenesin / Pseudoephedrine

Pediatric caution

Available as

20 MG/ML · Oral Solution200 MG · Oral Capsule400 MG · Oral Tablet190 MG · Oral Tablet50 MG/ML · Oral Solution375 MG · Oral Tablet1200 MG · Extended Release Oral Tablet600 MG · Extended Release Oral Tablet150 MG · Oral Capsule380 MG · Oral Tablet360 MG · Oral Tablet780 MG · Extended Release Oral Tablet

Multi-ingredient product

GuaifenesinPseudoephedrine

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)

16 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.