Summary
The AI claims evaluated are generic statements about dextromethorphan cough products and do not align with the provided AUVELITY (dextromethorphan hydrobromide + bupropion hydrochloride) FDA label excerpts, which instead focus on AUVELITY indications (MDD/agitation in dementia), dosing schedules, and bupropion/dextromethorphan-associated risks and specific contraindications/interactions. The provided label text does not support most of the cough-medicine/general-use statements.
Category Scores
Accurate Statements
Dextromethorphan can interact with certain antidepressants and other medicines that affect serotonin pathways.
Supported in principle by AUVELITY label: serotonin syndrome risk with concomitant use with SSRIs/tricyclic antidepressants/other serotonergic drugs (Warnings and Precautions 5.8; Drug Interactions 7.1).
Unsupported Statements
Dextromethorphan hydrobromide is a cough medicine ingredient used to treat cough.
Provided AUVELITY label excerpts indicate AUVELITY is for major depressive disorder and agitation associated with dementia due to Alzheimer’s disease; no cough-treatment claim is supported.
Dextromethorphan hydrobromide is commonly found in over-the-counter cough syrups and similar cold/cough products.
No such OTC/cough-product prevalence statement appears in the provided AUVELITY prescribing information excerpts.
Dextromethorphan hydrobromide helps suppress the cough reflex.
No cough-reflex mechanism statement is present in the provided AUVELITY label excerpts.
“Hydrobromide” is a salt form of dextromethorphan.
No salt-form/chemical-definition statement is provided in the excerpts.
Many medicine labels list the active ingredient as a specific salt such as hydrobromide.
No general statement about labeling conventions is present in the provided excerpts.
Cough medicines containing dextromethorphan may cause dizziness.
The adverse reaction data in provided excerpts are for AUVELITY clinical trials; the claim is framed as 'cough medicines containing dextromethorphan' and is not directly supported.
Cough medicines containing dextromethorphan may cause drowsiness.
AUVELITY adverse reactions include somnolence, but the claim is framed as cough medicines containing dextromethorphan; not directly supported as stated.
Cough medicines containing dextromethorphan may cause stomach upset.
The provided label excerpts mention dyspepsia/diarrhea in AUVELITY trials but do not support 'stomach upset' phrasing for cough medicines as stated.
Cough medicines containing dextromethorphan may cause nausea.
Nausea is not listed in the provided 'most common' adverse reactions excerpts.
Some people report headaches with cough medicines containing dextromethorphan.
AUVELITY excerpts list headache as a common adverse reaction, but the claim is framed as 'cough medicines containing dextromethorphan' rather than AUVELITY.
Risks are watched for when dextromethorphan is combined with alcohol.
The provided excerpts include contraindications involving abrupt discontinuation of alcohol, but do not state that 'risks are watched for' when dextromethorphan is combined with alcohol.
Risks are watched for when dextromethorphan is combined with other sedating drugs.
The provided excerpts do not state a general 'risks are watched for' statement regarding dextromethorphan combined with other sedating drugs.
Cough suppressant products typically start working within a short period after dosing.
No onset-of-action statement is present in the provided AUVELITY excerpts.
Contradictions
Low
AI Statement
Dextromethorphan hydrobromide is a cough medicine ingredient used to treat cough.
Label Reference
AUVELITY label excerpts provided: Indications are MDD in adults and agitation associated with dementia due to Alzheimer’s disease (Section 1.1 and 1.2).
Important Omissions
If discussing AUVELITY specifically, the provided label excerpts indicate key safety topics such as seizure risk (bupropion component), hypertension, serotonin syndrome, hyponatremia, contraindications (e.g., seizure disorder; MAOI use within 14 days), and concrete drug-interaction requirements (e.g., MAOIs). None of these AUVELITY-specific contraindications/warnings are addressed in the AI claims.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The claims are mostly generic and not directly prescribing AUVELITY use; however, they are largely unsupported by the provided AUVELITY prescribing information and could misdirect interpretation away from AUVELITY’s actual indications and contraindications.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Most claims are generic about cough medicines and do not correspond to the provided AUVELITY label excerpts (indications, dosing, and AUVELITY-specific safety/interaction language).
Suggested Improvement
Limit statements to what the AUVELITY label excerpts support: AUVELITY indications (MDD; agitation in dementia due to Alzheimer’s disease), bupropion-related seizure/contraindications, serotonin syndrome warnings with serotonergic drugs/MAOIs, and AUVELITY clinical-trial adverse reactions (e.g., dizziness, headache, diarrhea, somnolence, dyspepsia). Avoid cough-medicine/OTC prevalence/onset-of-action claims unless supported by the AUVELITY label text provided.