Partial
Mostly Misaligned
Patient Risk:
Moderate
Summary
The evaluated AI content largely discusses a different product (promethazine DM vs promethazine with codeine) and includes multiple statements not supported by the provided label excerpts; only the general idea of temporary cough relief in allergy/common cold aligns with the supplied INDICATIONS AND USAGE.
Category Scores
Accurate Statements
Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Supported by provided INDICATIONS AND USAGE text: “temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.”
Unsupported Statements
Promethazine DM usually refers to a cough syrup formulation that combines promethazine (an antihistamine) and dextromethorphan (a cough suppressant).
No label content provided for promethazine DM composition; supplied label excerpts are for promethazine with codeine syrup.
These products are used to help reduce coughing and related cold/flu symptoms.
Only “temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold” is provided; “cold/flu symptoms” wording is not supported by the supplied excerpts.
Promethazine DM products are typically marketed for short-term relief of cough caused by colds or other respiratory conditions.
The label excerpt provided does not mention “promethazine DM,” marketing claims, “other respiratory conditions,” or short-term language beyond the cited “temporary relief.”
Promethazine DM products are marketed for cough that interferes with sleep.
Not present in the supplied INDICATIONS AND USAGE excerpt.
Because ingredients include an antihistamine, promethazine DM can cause sleepiness.
The provided adverse reactions include drowsiness for promethazine, but no promethazine DM product context is provided; additionally, the supplied excerpt is for promethazine (within the promethazine with codeine syrup label section), not promethazine DM.
Promethazine DM may be used when calming/antihistamine effects are desired along with cough suppression.
No such therapeutic-use claim appears in the supplied label excerpts.
Dosing depends on the exact product strength and the patient’s age.
While age-based dosing is present for promethazine with codeine syrup, the statement is generic and does not match the provided dosing instructions which specify exact doses; “depends on exact product strength” is not supported by supplied text.
Promethazine-containing cough syrups are commonly prescribed/used with age-specific dosing limits due to safety concerns (especially in young children).
The supplied label excerpt includes a specific pediatric contraindication (<6 years) for promethazine/codeine combination, but “commonly prescribed/used” and generalized framing are not supported.
Promethazine can cause sedation.
The adverse reactions excerpt states “Drowsiness is the most prominent CNS effect” and also sedation/somnolence; however the statement is not explicitly tied to the specific product in the excerpt, and the evaluation set primarily contains promethazine DM claims not present in the label.
Using promethazine with alcohol, opioids, benzodiazepines, or other sedating medicines increases risk of dangerous drowsiness and breathing problems.
No drug-interaction or alcohol/benzodiazepine/opioid warning text is provided in the supplied excerpts.
Promethazine can impair alertness.
No label excerpt provided includes “impair alertness” or “alertness” wording.
Driving or operating machinery may be unsafe while using promethazine due to impaired alertness.
No “driving/operating machinery” precaution is provided in the supplied excerpts.
Dextromethorphan can interact with certain antidepressants.
No dextromethorphan or antidepressant interaction content is provided in the supplied label excerpts.
Monoamine oxidase inhibitors are associated with a higher risk of serious reactions with dextromethorphan.
Not present in supplied excerpts.
Promethazine DM indicates the presence of dextromethorphan plus promethazine.
No label content provided confirming this; the supplied label is for promethazine with codeine.
The exact strengths of promethazine-based cough syrups (including those labeled Promethazine DM) vary by manufacturer and country.
No labeling excerpt provided addressing cross-manufacturer/country strength variation.
Dosing depends on the exact product strength and the patient’s age.
Only specific dose amounts and age bands are provided; the “product strength variation” aspect is not supported.
Contradictions
Low
AI Statement
Promethazine DM ... combines promethazine and dextromethorphan.
Label Reference
Provided label excerpt states “Promethazine with codeine syrup” and includes contraindication and dosing for promethazine hydrochloride/codeine phosphate; no dextromethorphan is mentioned in the supplied label.
Important Omissions
The specific pediatric contraindication for promethazine hydrochloride/codeine phosphate in patients less than 6 years of age (fatal respiratory depression) and the importance of using an accurate measuring device with specific dosing limits.
Importance:
High
Safety Assessment
Potential Patient Risk:
Moderate
Multiple statements are not supported by the provided label excerpts and several refer to a different formulation (dextromethorphan vs codeine). The supplied label includes critical pediatric contraindication and precise dosing/measurement instructions that are not reflected in the evaluated content.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Mostly Misaligned
Primary Issue
Content discusses promethazine DM (dextromethorphan combination) but the provided label excerpts are for promethazine with codeine; key labeled contraindication and dosage/measurement instructions are not incorporated.
Suggested Improvement
Restrict claims to the provided label: use only the label-supported indication, include the <6 years contraindication and adult/child dosing ranges exactly as stated, and avoid dextromethorphan/MAOI interaction and driving/alcohol/benzodiazepine assertions unless those sections are included in the label excerpts.