Good
Mostly Aligned
Patient Risk:
Low
Summary
Most claims match the provided FDA label excerpts, particularly active ingredient, mechanism, indications, and several inactive-ingredient statements. A subset of inactive-ingredient claims for Prevacid 24 HR capsules are not supported by the label text provided (e.g., FD&C Blue No. 2, gelatin, hypromellose, microcrystalline cellulose, povidone, sodium lauryl sulfate, yellow iron oxide).
Category Scores
Accurate Statements
Prevacid is a brand name for lansoprazole.
11 DESCRIPTION
The active ingredient in Prevacid is lansoprazole.
11 DESCRIPTION
Lansoprazole is a proton pump inhibitor (PPI).
11 DESCRIPTION (inhibits gastric acid secretion)
Lansoprazole works by reducing the amount of acid produced in the stomach.
11 DESCRIPTION (inhibits gastric acid secretion)
Lansoprazole is prescribed for the treatment of gastroesophageal reflux disease (GERD) and its associated symptoms like heartburn.
1.7 Treatment of Symptomatic GERD
Lansoprazole is prescribed for the treatment of erosive esophagitis.
1.8 Treatment of Erosive Esophagitis (EE)
Lansoprazole is prescribed for healing and maintenance of healing of erosive esophagitis.
1.8 Treatment of EE; 1.9 Maintenance of Healing of EE
Lansoprazole is prescribed for conditions that cause the stomach to produce too much acid, such as Zollinger-Ellison syndrome.
1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Prevacid 24 HR capsules contain magnesium carbonate.
11 DESCRIPTION (delayed-release capsules inactive ingredients include magnesium carbonate)
Prevacid 24 HR capsules contain methacrylic acid copolymer.
11 DESCRIPTION (delayed-release capsules inactive ingredients include methacrylic acid copolymer)
Prevacid 24 HR capsules contain polyethylene glycol.
11 DESCRIPTION (delayed-release capsules inactive ingredients include polyethylene glycol)
Prevacid 24 HR capsules contain sugar spheres.
11 DESCRIPTION (delayed-release capsules inactive ingredients include sugar sphere)
Prevacid 24 HR capsules contain talc.
11 DESCRIPTION (delayed-release capsules inactive ingredients include talc)
Prevacid 24 HR capsules contain titanium dioxide.
11 DESCRIPTION (delayed-release capsules inactive ingredients include titanium dioxide)
Orally disintegrating tablet formulations of Prevacid may contain aspartame.
11 DESCRIPTION (PREVACID SoluTab inactive ingredients include aspartame)
Orally disintegrating tablet formulations of Prevacid may contain mannitol.
11 DESCRIPTION (PREVACID SoluTab inactive ingredients include mannitol)
Orally disintegrating tablet formulations of Prevacid may contain flavors.
11 DESCRIPTION (PREVACID SoluTab includes 'artificial strawberry flavor')
Unsupported Statements
Prevacid 24 HR capsules contain FD&C Blue No. 2.
Label text provided lists FD&C Blue No. 1 (and FD&C Red No. 28, FD&C Red No. 40) but does not list FD&C Blue No. 2 for delayed-release capsules.
Prevacid 24 HR capsules contain gelatin.
Gelatin is not listed among the delayed-release capsule inactive ingredients in the provided label excerpt.
Prevacid 24 HR capsules contain hypromellose.
Hypromellose is listed for PREVACID SoluTab (orally disintegrating tablets), not for PREVACID delayed-release capsules in the provided excerpt.
Prevacid 24 HR capsules contain microcrystalline cellulose.
Microcrystalline cellulose is not listed as an inactive ingredient for delayed-release capsules in the provided excerpt; it appears as part of a SoluTab sphere ingredient description.
Prevacid 24 HR capsules contain povidone.
Povidone is not listed among the delayed-release capsule inactive ingredients in the provided excerpt.
Prevacid 24 HR capsules contain sodium lauryl sulfate.
Sodium lauryl sulfate is not listed among delayed-release capsule inactive ingredients in the provided excerpt.
Prevacid 24 HR capsules contain yellow iron oxide.
The provided capsule inactive-ingredient list includes D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40, but does not list yellow iron oxide.
Contradictions
Low
AI Statement
Prevacid 24 HR capsules contain microcrystalline cellulose.
Label Reference
11 DESCRIPTION (capsules inactive ingredients list does not include microcrystalline cellulose; it appears in SoluTab sphere description instead)
Important Omissions
No dosage/administration claims were evaluated because the extracted claims set contains no dosing instructions (e.g., dose, frequency, treatment duration, or administration method) even though the schema requests dosage evaluation when relevant.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The only labeling mismatches are specific inactive-ingredient claims for PREVACID delayed-release capsules; no contraindications, boxed warnings, dosing, or other safety-critical claims were made in the provided extracted claims.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Multiple inactive-ingredient assertions for Prevacid 24 HR capsules are not supported by the provided label excerpt (and one ingredient-typing issue is present).
Suggested Improvement
Limit inactive-ingredient claims for PREVACID delayed-release capsules to the exact inactive ingredients listed in 11 DESCRIPTION; avoid attributing SoluTab excipients (e.g., hypromellose, microcrystalline cellulose components) to capsules unless explicitly supported.