Partial
Mostly Aligned
Patient Risk:
Moderate
Summary
Several safety and dosing-measurement details align with the provided label excerpts (e.g., pediatric <6 contraindication, sedation/drowsiness, accurate measuring device, dose concentration). However, multiple claims about specific interaction risks (alcohol, benzodiazepines, other sedating medicines, sleep apnea) and statements about “flavor” and dose confirmation are not supported by the supplied prescribing information excerpts.
Category Scores
Accurate Statements
Promethazine is an antihistamine.
The provided label excerpts do not explicitly state “antihistamine,” but “antihistamines and codeine are both contraindicated...” supports that promethazine is classified with antihistamines in-label context.
Promethazine can cause sedation.
ADVERSE REACTIONS - Promethazine: “Drowsiness is the most prominent CNS effect... Sedation, somnolence...”
Promethazine can affect alertness.
ADVERSE REACTIONS - Promethazine includes CNS effects such as “drowsiness,” “sedation,” “somnolence,” and CNS impairment symptoms (e.g., blurred vision, dizziness).
Codeine can suppress breathing.
ADVERSE REACTIONS - Codeine: “CNS depression, particularly respiratory depression...”
The 'flavor' part usually does not change the active ingredients.
No label excerpt provided in the prompt addresses flavor or active-ingredient changes.
Promethazine-codeine combination products are used for cough symptoms in some patients.
INDICATIONS AND USAGE: “temporary relief of coughs and upper respiratory symptoms...”
For promethazine-codeine syrups, concentration and dosing instructions on the prescription label are the most important details.
DOSAGE AND ADMINISTRATION includes “Each 5 mL... contains” (concentration) and dosing instructions; and PRECAUTIONS includes need for accurate measurement to avoid overdosage. (The specific statement about “prescription label” is not explicitly stated, but label does emphasize dosing/concentration and accurate measurement.)
Promethazine-codeine syrups should be measured with an accurate measuring device (not a household teaspoon).
DOSAGE AND ADMINISTRATION: “It is important... measured with an accurate measuring device... A household teaspoon is not an accurate measuring device and could lead to overdosage...”
Unsupported Statements
The risk of breathing suppression from codeine is higher in children.
The provided excerpts only specify pediatric contraindication for ages <6 due to risk of fatal respiratory depression; they do not provide an explicit statement about higher risk across children broadly.
The risk of breathing suppression from codeine is higher in people with sleep apnea or other breathing problems.
No sleep apnea or other specific breathing-condition risk stratification is present in the supplied label excerpts.
Promethazine-codeine products can have dangerous interactions with alcohol.
No alcohol-interaction warning appears in the provided label excerpts.
Promethazine-codeine products can have dangerous interactions with other sedating medicines.
No general sedating-medicine interaction warning appears in the provided label excerpts.
Benzodiazepines are an example of sedating medicines that can interact dangerously with promethazine-codeine products.
No benzodiazepine-specific interaction content appears in the provided label excerpts.
Other opioids are an example of sedating medicines that can interact dangerously with promethazine-codeine products.
No interaction content regarding other opioids appears in the provided label excerpts.
The flavor can change the product’s taste and how it is administered, typically oral liquid.
No “flavor” or formulation/taste/admin route-changing information appears in the provided label excerpts.
The flavor can change the exact formulation and concentration shown on the label.
No “flavor” or concentration-changing information appears in the provided label excerpts.
Sellers may describe the item in a way that makes it hard to confirm the real active dose without the label.
No marketplace/seller description guidance appears in the provided label excerpts.
Codeine carries a misuse/dependence risk because codeine is an opioid.
The label excerpt includes section headings (“DRUG ABUSE AND DEPENDENCE”) but provides no content; no misuse/dependence statement is included in the supplied excerpts.
The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
This statement is supported by the provided contraindications excerpt; therefore it should not be listed as unsupported. (Note: it was included in the input list; included here only if this specific claim was not otherwise evaluated as accurate due to mapping error.)
Promethazine-codeine products can have dangerous interactions with alcohol.
No alcohol-interaction warning appears in the provided label excerpts.
Contradictions
Low
AI Statement
The 'flavor' part usually does not change the active ingredients.
Label Reference
Important Omissions
Key contraindication details beyond pediatric <6 years (e.g., codeine hypersensitivity; promethazine comatose states and hypersensitivity/idiosyncratic reaction to promethazine/phenothiazines; contraindication in lower respiratory tract symptoms including asthma).
Importance:
Moderate
Specific boxed warning/precautions content (the provided prompt includes only headings; no boxed warning text or detailed warnings/precautions content is included in the excerpts provided).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Unsupported interaction claims (alcohol, benzodiazepines, other sedating medicines) and unsupported risk stratifications (sleep apnea/other breathing problems, higher risk across children) could mislead safety risk perception if relied upon; however, several core contraindication and sedation/respiratory depression statements are aligned with the supplied label excerpts.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Mostly Aligned
Primary Issue
Multiple safety/interaction and “flavor/marketplace” claims are not supported by the provided prescribing information excerpts.
Suggested Improvement
Restrict claims to what is explicitly present in the supplied label text (e.g., sedation/drowsiness; respiratory depression; pediatric <6 contraindication; accurate measuring device and dosing limits). Remove or qualify unsupported alcohol/benzodiazepine/sedating-medicine interaction and sleep apnea-specific risk statements, and remove unsupported “flavor” and seller/label-confirmation assertions.