Poor
Not Aligned
Patient Risk:
High
Summary
Only the pediatric <2 years fatal respiratory depression risk is directly supported by the provided label excerpts; many other statements (e.g., specific warnings about driving/falls, misuse/dependence, and various drug co-use harms) are not supported by the provided label text.
Category Scores
Accurate Statements
Promethazine with codeine is a combination medicine intended for cough associated with cold or other upper-respiratory conditions.
Label excerpt provided is for promethazine hydrochloride and dextromethorphan hydrobromide oral solution indicated for temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold (SECTION 1 INDICATIONS AND USAGE).
Caution is recommended in children when using promethazine with codeine.
Label excerpt: caution should be exercised when administering to pediatric patients 2 years of age and older; lowest effective dose and avoid concomitant administration of other drugs with respiratory depressant effects (WARNINGS – Black Box Warning / Use in Pediatric Patients).
Caution is recommended in people with breathing disorders when using promethazine with codeine.
Concomitant administration with other respiratory depressants has an association with respiratory depression and sometimes death in pediatric patients (Use in Pediatric Patients text). Note: provided excerpt does not explicitly mention 'breathing disorders' as a phrase, but it supports caution regarding respiratory depressant coadministration.
Respiratory depression is a safety risk associated with promethazine with codeine.
Boxed/pediatric warning language and adverse reactions excerpt: respiratory depression (potentially fatal) and apnea (potentially fatal) (ADVERSE REACTIONS) and overdosage includes respiratory depression and sudden death (OVERDOSAGE excerpt).
Combining promethazine with codeine with other central nervous system depressants increases the risk of profound sedation.
Drug interactions excerpt: promethazine may increase, prolong, or intensify the sedative action of other CNS depressants such as alcohol, sedatives/hypnotics, narcotics, etc. Therefore CNS depressants should be avoided or reduced dosage.
Combining promethazine with codeine with other central nervous system depressants increases the risk of breathing problems.
Use in Pediatric Patients excerpt: concomitant administration with other respiratory depressants has an association with respiratory depression and sometimes death in pediatric patients.
Unsupported Statements
Promethazine with codeine is a combination medicine intended for cough associated with cold or other upper-respiratory conditions.
The provided label excerpts are for promethazine hydrochloride and dextromethorphan hydrobromide oral solution, not promethazine with codeine.
Promethazine is an antihistamine in promethazine with codeine.
Not supported by the provided label excerpts.
Codeine is an opioid antitussive in promethazine with codeine.
Not supported by the provided label excerpts (the excerpts describe dextromethorphan, not codeine).
Drowsiness and sedation are safety risks associated with promethazine with codeine.
Provided excerpts do not explicitly list sedation/drowsiness as an adverse reaction; only CNS depressant intensification is described in drug interactions.
Drowsiness and sedation from promethazine with codeine can impair driving.
Not supported by the provided label excerpts.
Drowsiness and sedation from promethazine with codeine can increase fall risk.
Not supported by the provided label excerpts.
The risk of respiratory depression with promethazine with codeine is especially increased when combined with other sedatives.
Label excerpt supports increased respiratory depression with other respiratory depressants in pediatric patients, but the statement specifically attributes risk to 'other sedatives' and 'especially increased' broadly; the provided text is not that specific.
Serious harm can occur when promethazine with codeine is used with alcohol.
Drug interactions excerpt says promethazine may increase/intensify sedative action of alcohol and other CNS depressants; it does not state 'serious harm' specifically in the provided text.
Serious harm can occur when promethazine with codeine is used with benzodiazepines.
The provided drug interactions excerpt lists sedatives/hypnotics and tranquilizers generally; 'benzodiazepines' are not explicitly named in the provided excerpts.
Serious harm can occur when promethazine with codeine is used with sleep medications.
The provided drug interactions excerpt references sedatives/hypnotics generally; 'sleep medications' are not explicitly stated and no 'serious harm' wording is provided.
Serious harm can occur when promethazine with codeine is used with other opioids.
The provided interactions excerpt mentions narcotics/opioids generally as CNS depressants and recommends avoiding or reducing dosage; it does not explicitly state 'serious harm' in the provided text.
Promethazine with codeine carries a risk of misuse and dependence because it contains codeine.
Not supported by the provided label excerpts.
Codeine’s effects depend on metabolism.
Not supported by the provided label excerpts.
Some people metabolize codeine more rapidly.
Not supported by the provided label excerpts.
Rapid metabolism of codeine can lead to higher-than-expected opioid levels.
Not supported by the provided label excerpts.
Higher-than-expected opioid levels from codeine increase the risk of toxicity.
Not supported by the provided label excerpts.
Clinicians are careful about patient selection and dosing for codeine-containing cough products.
Not supported by the provided label excerpts.
Patent status can influence when manufacturers enter or switch products for Wockhardt versions.
Not supported by the provided label excerpts (this is not a prescribing-information claim).
Contradictions
Low
AI Statement
Promethazine with codeine is a combination medicine intended for cough associated with cold or other upper-respiratory conditions.
Label Reference
FDA label excerpts provided are for promethazine hydrochloride and dextromethorphan hydrobromide oral solution (SECTION 1 INDICATIONS AND USAGE).
Low
AI Statement
Codeine is an opioid antitussive in promethazine with codeine.
Label Reference
The provided label excerpts describe dextromethorphan hydrobromide (SECTION 1 INDICATIONS AND USAGE and Drug/interactions excerpts context).
Low
AI Statement
The risk of respiratory depression with promethazine with codeine is especially increased when combined with other sedatives.
Label Reference
Use in Pediatric Patients excerpt: risk is associated with concomitant administration of other respiratory depressants in pediatric patients, not specifically 'other sedatives' broadly.
Important Omissions
The label explicitly contraindicates the oral solution for pediatric patients less than 2 years of age (contraindication), with a boxed warning rationale including potential fatal respiratory depression and caution for ≥2 years with avoidance of concomitant respiratory depressants.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
High
Multiple claims are not supported by the provided label excerpts and the response appears to conflate 'promethazine with codeine' with labeling for 'promethazine with dextromethorphan,' which could misalign safety and risk information.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Response repeatedly uses 'promethazine with codeine' and 'codeine' claims, while the provided label excerpts are for promethazine hydrochloride + dextromethorphan hydrobromide; several other safety claims (driving/falls/misuse-dependence/metabolism specifics) are not supported by the provided excerpts.
Suggested Improvement
Restrict statements to the provided label excerpts (promethazine HCl/dextromethorphan oral solution). Explicitly use the boxed pediatric <2 years fatal respiratory depression contraindication language and avoid adding unsupported claims about driving, falls, misuse/dependence, or codeine metabolism.