Poor
Not Aligned
Patient Risk:
High
Summary
Multiple clinically significant claims about codeine/opioid-specific effects (sedation/breathing problems, constipation, and overdose risk especially from codeine) are not supported by the provided FDA label excerpts. Several component attribution and dosing-context claims are also unsupported, and at least one label-support determination is internally unreliable due to incomplete excerpt coverage.
Category Scores
Accurate Statements
“Alcohol is a major caution area when using acetaminophen plus codeine.”
WARNINGS excerpt: “Avoid alcoholic beverages while taking this product” and “alcohol… may increase the drowsiness effect.” Component linkage to acetaminophen+codeine is not explicitly shown, but the alcohol caution itself is supported for the product.
Unsupported Statements
In many places, “COD 3” means acetaminophen plus codeine.
Not supported; determination marked 'contradicted' but relies on incomplete/partial excerpt comparison and does not reliably establish label contradiction with the provided text. (Codeine is not reflected in the provided label excerpts.)
Acetaminophen is the pain/fever component.
Only partially supported: INDICATIONS_AND_USAGE supports aches/pains and fever reduction, but provided excerpt does not explicitly attribute those effects to acetaminophen as the component.
Codeine adds opioid pain relief.
No codeine or opioid activity described in the provided label excerpts.
The acetaminophen plus codeine dosing depends on the specific product strength, the patient’s age, and other medicines the patient takes.
No dosing guidance for acetaminophen+codeine or codeine-containing regimens appears in provided excerpts.
Acetaminophen can harm the liver if total daily intake is too high.
No liver injury/total daily intake limit warning in the provided excerpts.
Codeine can cause dangerous sedation or breathing problems in some people.
Provided WARNINGS only mention drowsiness and avoidance of alcohol/sedatives/tranquilizers; codeine-specific respiratory risk is not supported.
With acetaminophen plus codeine, commonly reported side effects include sleepiness, dizziness, constipation (from codeine), and nausea or stomach upset.
WARNINGS support drowsiness and avoidance cautions, but no label support in provided excerpts for 'commonly reported' constipation or nausea, nor attribution to codeine.
There is a risk of overdose if acetaminophen plus codeine is taken in too high a dose, especially from codeine.
Overdose guidance is generic (“seek… Poison Control Center”), and the excerpt does not attribute overdose risk to codeine specifically.
There is a risk of liver injury if acetaminophen limits are exceeded, especially from combining multiple acetaminophen-containing products.
No liver injury or acetaminophen-combination limit guidance in the provided excerpts.
Cold/flu medications can contain acetaminophen, and total acetaminophen can add up quickly.
No warning about other cold/flu products or cumulative acetaminophen exposure appears in the provided excerpts.
Other sedating medicines (some sleep meds, anxiety meds, muscle relaxers, or other opioids) can increase breathing/sedation risk when combined with acetaminophen plus codeine.
WARNINGS only support increased drowsiness with alcohol/sedatives/tranquilizers; it does not name these drug classes or support 'breathing risk' or 'opioids' in combination.
Contradictions
Low
AI Statement
In many places, “COD 3” means acetaminophen plus codeine.
Label Reference
OVERDOSAGE (provided excerpt references phenyltoloxamine citrate or acetaminophen; codeine is not shown in provided excerpts).
Important Omissions
No label-backed dosing limits, administration instructions, or product-specific guidance for acetaminophen/codeine dosing is provided in the AI claims set.
Importance:
Moderate
No reconciliation with provided contraindication/hypersensitivity information is included (AI makes no such statement).
Importance:
Low
Safety Assessment
Potential Patient Risk:
High
Several claims introduce or imply opioid-specific risks (sedation/breathing problems, codeine-attributed constipation, overdose risk 'especially from codeine') that are not supported by the provided label excerpts, which could mislead users about the basis of safety counseling.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Not Aligned
Primary Issue
Unsupported opioid/component-specific claims (codeine) and overreaching safety/side-effect counseling not evidenced in the provided FDA label excerpts.
Suggested Improvement
Restrict claims to what is explicitly supported by the provided label sections (INDICATIONS_AND_USAGE and WARNINGS/OVERDOSAGE excerpts), and remove component-specific dosing and codeine-specific safety/side-effect statements unless the exact corresponding label text for codeine-containing product risks is provided.