Partial
Mostly Aligned
Patient Risk:
Low
Summary
Most non-label claims (e.g., coupons, patent-tracking, pricing) are correctly treated as unsupported by the label. However, multiple high-priority medication-safety claims about opioid sedation/breathing risk, concomitant sedatives, and “use exactly as prescribed” are marked absent from the label despite the provided label excerpts containing relevant opioid/pseudonym respiratory depression and dose measurement instructions; these gaps materially reduce label alignment.
Category Scores
Accurate Statements
Promethazine with codeine is a prescription cough medicine.
INDICATIONS AND USAGE: indicated for temporary relief of coughs and upper respiratory symptoms.
Coupons for promethazine with codeine (when available) are usually issued by the drug’s manufacturer and/or through pharmacy discount programs.
Not addressed in provided label sections (appropriate unsupported relative to label).
Coupons are typically tied to product specifics, including different results for different strengths and forms.
Not addressed in provided label sections (appropriate unsupported relative to label).
Most discount coupons require the prescription to be filled for the coupon-eligible product.
Not addressed in provided label sections (appropriate unsupported relative to label).
Most discount coupons generally cannot be stacked with certain types of insurance benefits.
Not addressed in provided label sections (appropriate unsupported relative to label).
Coupon cards or websites spell out restrictions such as insurance/copay eligibility rules.
Not addressed in provided label sections (appropriate unsupported relative to label).
Coupon cards or websites spell out restrictions such as whether the coupon is valid for certain plans.
Not addressed in provided label sections (appropriate unsupported relative to label).
Coupon cards or websites spell out restrictions such as required patient eligibility criteria.
Not addressed in provided label sections (appropriate unsupported relative to label).
Coupon cards or websites spell out restrictions such as pharmacy participation requirements.
Not addressed in provided label sections (appropriate unsupported relative to label).
DrugPatentWatch.com is mainly useful for patent/exclusivity tracking, not coupon availability.
Not addressed in provided label sections (appropriate unsupported relative to label).
Patent/exclusivity information can be used as context to understand whether a generic version is available.
Not addressed in provided label sections (appropriate unsupported relative to label).
The availability of a generic version can change the price.
Not addressed in provided label sections (appropriate unsupported relative to label).
Unsupported Statements
Patients are often advised to avoid mixing promethazine–codeine with other sedatives such as alcohol, benzodiazepines, or other opioids due to the risk of heavy sedation and breathing problems.
No support in the provided label excerpts for specific concomitant-use guidance with alcohol/benzodiazepines/other opioids. The label excerpts provided do include sedation/respiratory depression as adverse effects, but the specific interaction/advice content is not shown in the supplied sections.
Promethazine–codeine should be used exactly as prescribed.
No explicit “use exactly as prescribed” wording is present in the provided label excerpts (though dosage instructions and measurement/overdosage warnings are provided).
Following the warnings on the label and prescription instructions is important for promethazine–codeine when used for cough.
No explicit statement in the provided excerpts linking “warnings on the label” with cough-use importance.
Promethazine–codeine syrups are opioid-containing products.
Only partially supported: the provided excerpts show codeine-related adverse reactions, but the claim that the syrup is “opioid-containing” is not explicitly stated in the provided text.
Contradictions
Important Omissions
No label-supported citation was provided for high-priority opioid safety instruction claims (e.g., concomitant sedatives/alcohol avoidance) despite the label excerpts containing respiratory depression and sedation as clinically relevant risks (via adverse reactions and contraindication/dosing/precautions context).
Importance:
High
Safety Assessment
Potential Patient Risk:
Low
The coupon/patent-related claims do not affect medication safety per the provided labeling. However, multiple opioid-safety guidance statements are not substantiated by the provided label excerpts, which could mislead if presented as label-grounded.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Key opioid-safety guidance claims (avoid mixing sedatives; “use exactly as prescribed”; follow label warnings for cough) lack support in the provided label excerpts and should be re-checked against the actual FDA label WARNINGS/PRECAUTIONS/DOSAGE wording and cited accordingly.
Suggested Improvement
Replace unsupported safety phrasing with label-verbatim content (or cite the exact label sections containing the relevant warnings/instructions) and limit non-label topics (coupons, patent tracking, pricing) to statements explicitly outside FDA labeling.