Good
Partially Aligned
Patient Risk:
Moderate
Summary
Most safety- and control-related claims are directionally consistent with the label excerpts provided (e.g., Schedule V, prescription-only, respiratory depression warnings, pediatric contraindication). However, several statements are not supported by the provided label text (notably OTC ingredient claims, counterfeit legality/OTC effectiveness, and some dispensing/illegal-purchase assertions). Label-mismatched claims were not identified as direct contradictions, but support is limited by what label excerpts contain.
Category Scores
Accurate Statements
Promethazine with codeine is a Schedule V controlled substance in the United States.
Drug Abuse and Dependence section: “Schedule V Controlled Substance.”
Promethazine with codeine requires a valid prescription from a licensed healthcare provider for legal purchase from a pharmacy.
Label excerpt provided states drug is prescription/controlled via Schedule V, but does not explicitly state the “licensed healthcare provider” wording in the provided text.
Promethazine with codeine has potential for abuse and dependence.
Drug Abuse and Dependence section: “Psychological dependence, physical dependence, and tolerance are known to occur with codeine.”
As a controlled substance, promethazine with codeine is subject to regulations by the Drug Enforcement Administration (DEA).
Label excerpt provided indicates Schedule V controlled substance; does not explicitly mention DEA in provided label text.
Promethazine with codeine is regulated as a prescription-only medication by the U.S. Food and Drug Administration (FDA).
Not explicitly supported by provided label excerpts; FDA wording not shown.
Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Indications and Usage (1): “indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.”
Promethazine with codeine contraindication exists in pediatric patients less than 6 years of age due to fatal respiratory depression risk.
Contraindications and Warnings: “contraindicated in pediatric patients less than 6 years of age… may cause fatal respiratory depression.”
There is a risk of respiratory depression and potentially fatal respiratory depression.
Warnings/Precautions and Adverse Reactions excerpts: “Respiratory… respiratory depression (potentially fatal)” and “Promethazine may lead to potentially fatal respiratory depression.”
Over-the-counter cough suppressants and expectorants such as dextromethorphan can be effective for managing cough symptoms.
Not supported by provided label excerpts.
Over-the-counter cough suppressants and expectorants such as guaifenesin can be effective for managing cough symptoms.
Not supported by provided label excerpts.
Concomitant administration with other respiratory depressants is associated with respiratory depression, sometimes death, in pediatric patients.
Warnings excerpt: “Concomitant administration… association with respiratory depression, and sometimes death, in pediatric patients.”
Promethazine may impair mental/physical abilities and CNS depression may be amplified by concomitant use of other CNS depressants; such agents should be eliminated or reduced.
Warnings/Precautions excerpt: “CNS Depression… impairment may be amplified by concomitant use of other central-nervous-system depressants… agents should either be eliminated or… reduced dosage.”
Respiratory depression risk in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.
Warnings/Precautions excerpt: “Use of Promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.”
Unsupported Statements
Promethazine with codeine cough syrup price varies depending on dosage, quantity, and the specific pharmacy or distributor.
Not addressed in the provided FDA label excerpts.
The cost of promethazine with codeine can be influenced by insurance coverage.
Not addressed in the provided FDA label excerpts.
A prescription for promethazine with codeine without insurance can range from approximately $20 to over $100 for a standard bottle.
Not addressed in the provided FDA label excerpts.
A 4-ounce bottle of promethazine with codeine might cost around $30 to $50.
Not addressed in the provided FDA label excerpts.
The price of promethazine with codeine can differ between brand-name versions and generic formulations.
Not addressed in the provided FDA label excerpts.
It is illegal to buy or sell promethazine with codeine without a prescription.
Not addressed in the provided FDA label excerpts.
Products offered without a prescription are often counterfeit.
Not addressed in the provided FDA label excerpts.
Counterfeit promethazine with codeine may be dangerous.
Not addressed in the provided FDA label excerpts.
Counterfeit promethazine with codeine may not contain the advertised ingredients or dosages.
Not addressed in the provided FDA label excerpts.
Purchasing promethazine with codeine from unregulated sources carries risks including receiving a product that is contaminated.
Not addressed in the provided FDA label excerpts.
Purchasing promethazine with codeine from unregulated sources carries risks including receiving incorrect or harmful ingredients.
Not addressed in the provided FDA label excerpts.
Purchasing promethazine with codeine from unregulated sources carries risks including receiving a different strength than indicated.
Not addressed in the provided FDA label excerpts.
There is a risk of legal repercussions for possessing controlled substances without a prescription.
Not addressed in the provided FDA label excerpts.
Promethazine with codeine is regulated as a prescription-only medication by the U.S. Food and Drug Administration (FDA).
Provided label excerpts do not explicitly state “FDA prescription-only.”
Pharmacies are required to dispense promethazine with codeine only with a valid prescription.
Not addressed in the provided FDA label excerpts.
Over-the-counter cough suppressants and expectorants such as dextromethorphan can be effective for managing cough symptoms.
Not addressed in the provided FDA label excerpts.
Over-the-counter cough suppressants and expectorants such as guaifenesin can be effective for managing cough symptoms.
Not addressed in the provided FDA label excerpts.
Promethazine with codeine requires a valid prescription from a licensed healthcare provider for legal purchase from a pharmacy.
Provided label excerpts confirm Schedule V/contraindication/warnings but do not explicitly include “licensed healthcare provider” phrasing or “legal purchase” process wording.
Contradictions
Important Omissions
Dosage and administration details (adult and pediatric age-based dosing intervals and maximum daily volume) are not provided in the AI response list; only non-label financial/control statements are included.
Importance:
Moderate
Key contraindications besides pediatric age (e.g., comatose states; hypersensitivity; contraindication in lower respiratory tract symptoms including asthma) are not stated in the AI response list.
Importance:
Moderate
Specific warnings relevant to drug interactions and pediatric risk (e.g., warning about concomitant respiratory depressants and CNS depressants) are only partially covered; details on avoiding use in compromised respiratory function are included but other interaction specifics are not.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Safety-relevant label concepts (Schedule V, pediatric contraindication/respiratory depression, CNS/CNS depressants) are mentioned, but several other claims are unsupported and there is a major omission of dosing/administration limits and other contraindications that are material for safe use.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Many statements (pricing, counterfeit/legal assertions, OTC ingredient efficacy, and pharmacy dispensing/DEA/FDA wording) are not supported by the provided FDA label excerpts, while important label content (dosing limits and additional contraindications) is omitted.
Suggested Improvement
Limit claims to what the label excerpts support: indication; Schedule V/abuse/dependence (from label); pediatric <6 years contraindication and respiratory depression/CNS depression warnings; include dosing and maximum daily volume and other stated contraindications if making clinical safety statements.