Poor
Needs Review
Patient Risk:
Medium
Summary
Only the pediatric fatal respiratory depression claim is supported by the provided label excerpts; the provided response set includes many claims that are not evaluated against the label content given (notably that the drug contains codeine/opioid/schedule/cough-syrup controlled substance), and the label excerpts provided appear to be for a promethazine + dextromethorphan product rather than promethazine codeine.
Category Scores
Accurate Statements
FDA label support assessment for pediatric use safety warning about fatal respiratory depression in children <2 years.
WARNINGS — Black Box Warning (Boxed Warning) and WARNINGS — Use in Pediatric Patients and 2 DOSAGE AND ADMINISTRATION indicate promethazine-containing products are contraindicated in pediatric patients < 2 years due to potential for fatal respiratory depression with postmarketing fatalities.
Unsupported Statements
Akorn's Promethazine Codeine Syrup (Phenergan with Codeine) is a prescription medication used to relieve symptoms of cough and upper respiratory symptoms associated with allergies or the common cold.
The provided label excerpts are for promethazine hydrochloride and dextromethorphan hydrobromide oral solution (Promethazine DM), not promethazine codeine. No provided excerpt supports promethazine codeine labeling/indication.
Akorn's Promethazine Codeine Syrup contains promethazine.
While promethazine hydrochloride appears in the provided label excerpts, the response set repeatedly refers to a codeine-containing product; the provided label excerpt does not establish that the specific referenced product (promethazine codeine syrup) contains promethazine.
Promethazine is an antihistamine that reduces the effects of histamine in the body.
No provided label excerpt supports this pharmacologic description.
Akorn's Promethazine Codeine Syrup contains codeine.
The provided label excerpts list promethazine hydrochloride and dextromethorphan hydrobromide, not codeine.
Codeine is an opioid that relieves pain and suppresses cough.
No provided label excerpt supports this statement.
Promethazine codeine can cause dizziness.
No provided label excerpt supports dizziness as an adverse effect.
Promethazine codeine can cause drowsiness.
No provided label excerpt supports drowsiness as an adverse effect.
Promethazine codeine can cause constipation.
No provided label excerpt supports constipation as an adverse effect.
Promethazine codeine can cause nausea.
No provided label excerpt supports nausea as an adverse effect.
Promethazine codeine can cause vomiting.
No provided label excerpt supports vomiting as an adverse effect.
Promethazine codeine can cause slowed breathing.
No provided label excerpt supports “slowed breathing” wording as an adverse effect.
Promethazine codeine can cause respiratory depression.
The label excerpts support respiratory depression for promethazine products, but they are for promethazine hydrochloride (in the combination product shown). The response claims are specifically tied to “promethazine codeine,” which is not established by the provided excerpts.
Promethazine codeine can lead to addiction and abuse due to the codeine component.
No provided label excerpt supports addiction/abuse risks or controlled-substance related warnings.
In the United States, codeine-containing cough syrups are Schedule V controlled substances requiring a prescription.
No provided label excerpt contains scheduling requirements.
In the United States, codeine-containing cough syrups require careful monitoring by healthcare professionals.
No provided label excerpt states this monitoring requirement for codeine-containing cough syrups.
Regulatory bodies like the FDA have issued warnings and recommendations regarding the use of codeine in pediatric populations due to safety concerns.
No provided label excerpt includes such regulatory statements.
Promethazine codeine is a combination of established active pharmaceutical ingredients whose original patents for the individual drugs have long expired.
No provided label excerpt supports patent/market exclusivity assertions.
Contradictions
Low
AI Statement
Akorn's Promethazine Codeine Syrup contains codeine.
Label Reference
Provided label excerpts indicate promethazine hydrochloride and dextromethorphan hydrobromide oral solution (Promethazine DM) rather than codeine-containing product.
Important Omissions
For the supported pediatric safety issue, the response set does not provide the key label details needed for accuracy: contraindication threshold (<2 years) and the boxed warning’s emphasis on fatal respiratory depression/postmarketing fatalities and caution/avoidance of concomitant respiratory depressants in children ≥2 years.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Medium
Only the pediatric fatal respiratory depression warning is supported by the provided label excerpts; many other claims are unsupported and include ingredient mismatch (codeine vs dextromethorphan), which could lead to misrepresentation of the product’s safety profile relative to the provided label.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Needs Review
Primary Issue
Major product mismatch and many unsupported pharmacologic/controlled-substance/adverse-effect claims; only the pediatric <2 years fatal respiratory depression boxed-warning concept aligns with provided label excerpts.
Suggested Improvement
Restrict claims to the provided label’s product composition (promethazine hydrochloride + dextromethorphan hydrobromide) and only state supported boxed-warning/pediatric contraindication language; remove or re-verify any codeine-, opioid-, Schedule-, and specific adverse-effect claims that are not present in the supplied label text.