FDA.reportPublic FDA data

FDA label 5fdbd552-5aad-418a-86ab-dfae29fa9a8a

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID
ffcfc152-3232-4a88-9b78-e6981fc87684
SPL ID
5fdbd552-5aad-418a-86ab-dfae29fa9a8a
Version
3
Effective date
2023-05-10
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:14:09

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: Initial exacerbation of symptoms may occur. If conditions worsen or persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician. Consulta a physician if the following symptoms occur: vomiting, change in stool, fever, lethargy, or poor weight gain. Do not exceed recommended dosage. As with all medications, it is important to ensure that your child’s medical professional is aware of the use of this product.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.