warnings
WARNING As in the case of all medications, keep out of the reach of children. Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
FDA label 61d02e8e-399f-4508-b768-b5f6f6bd29bc
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 378704e2-1d34-4816-b8e7-56b1d17bff27
- SPL ID
- 61d02e8e-399f-4508-b768-b5f6f6bd29bc
- Version
- 16
- Effective date
- 2012-11-30
- Source export date
- 2026-10-12
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:32:25
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 61d02e8e-399f-4508-b768-b5f6f6bd29bc | id | |
| spl set id | 378704e2-1d34-4816-b8e7-56b1d17bff27 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.