Good
Partially Aligned
Patient Risk:
Low
Summary
Most factual statements about cromolyn sodium as the active ingredient and general product status are likely consistent, but multiple claims about formulation-specific variations (inactive ingredients, countries/markets) are not supported by the provided FDA label excerpts and therefore reduce alignment.
Category Scores
Accurate Statements
Gastrocrom’s active ingredient is cromolyn sodium.
Supported insofar as the provided label excerpts describe GASTROCROM as containing cromolyn sodium (e.g., contraindications and warnings reference hypersensitivity to cromolyn sodium; Clinical Pharmacology discusses cromolyn sodium).
Gastrocrom is a prescription medicine.
Not directly supported by the provided excerpts; however, the label context provided is consistent with FDA prescribing information. No explicit section excerpt confirming 'prescription only' was included.
Gastrocrom is commonly supplied as an oral solution.
Partially supported by the dosage form provided in the prompt ('Oral concentrate ... ampules; for oral use'). The excerpted label text does not explicitly say 'commonly supplied as an oral solution.'
Depending on the market or formulation, Gastrocrom may be supplied in oral capsule or liquid form.
Not supported by the provided label excerpts.
Unsupported Statements
The exact ingredient list for Gastrocrom can vary by the specific formulation and country.
The provided label excerpts do not discuss variability of ingredient lists by country/market.
Inactive ingredients in Gastrocrom can vary across formulations.
The provided label excerpts do not discuss inactive ingredient composition or variability.
Inactive ingredients may include preservatives, sweeteners, and flavorings.
No inactive ingredient examples are provided in the supplied label excerpts.
Inactive ingredients can change over time due to manufacturing, stability, or regulatory updates.
No label excerpt addresses changes in inactive ingredients over time.
Two Gastrocrom boxes from different dates or regions can list different inactive ingredients while keeping cromolyn sodium as the active component.
The provided label excerpts do not address packaging-date/region differences in inactive ingredients.
Contradictions
Important Omissions
If making claims about dosage form variants (capsule vs oral liquid) or ingredient variability, the specific label section(s) that list dosage forms and inactive ingredients (e.g., 'Description' or 'How supplied/Composition' typically) are not provided in the prompt, preventing confirmation.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The unsupported statements relate to inactive ingredient variability and formulation variation, which are not directly used for dosing or contraindications in the provided excerpts. Without label support, there is a risk of misinformation but no direct dosing/safety contraindication conflict can be identified from the provided text.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Multiple claims about country/market-dependent formulations and inactive ingredient variability are not supported by the provided FDA label excerpts.
Suggested Improvement
Limit statements to elements explicitly supported by the provided label text (e.g., cromolyn sodium as the active ingredient; oral concentrate/ampules for oral use). Remove or qualify claims about inactive ingredient lists, preservatives/sweeteners/flavorings, and box-to-box regional/date differences unless the corresponding label sections listing inactive ingredients and product variations are provided.