Drug Reference

Codeine / Guaifenesin / Pseudoephedrine

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Pediatric contraindication

Brand names

Ambifed CDAmbifed-G CDBiotussinLortuss EXZodryl DEC

Available as

1 MG/ML · Oral Suspension10 MG · Oral Tablet2 MG/ML · Oral Solution20 MG · Oral Tablet
Multi-ingredient product
CodeineGuaifenesinPseudoephedrine

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 contraindication

Contraindicated for pain or cough in children <12 years; carries an FDA boxed warning. Also contraindicated in children <18 after tonsillectomy/adenoidectomy and in adolescents 12–18 who are obese or have OSA/respiratory compromise, due to ultra-rapid metabolism and fatal respiratory depression.

Source: FDA Drug Safety Communication 2017; codeine prescribing information (boxed warning).

⚑ 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)

26 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.