FDA.reportPublic FDA data

FDA label 5c511064-e134-098f-e053-2a91aa0a0f1e

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
edc6c44f-90ad-43f0-a602-83c2751a08c1
SPL ID
5c511064-e134-098f-e053-2a91aa0a0f1e
Version
4
Effective date
2017-10-24
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:33

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 Do not use more often than directed for more than 7 days in a row unless directed by a doctor or dentist if your child has a known allergy to any ingredient in this product Stop use and ask a doctor if symptoms persist for more than 7 days or worsen swelling, rash, or fever develops irritation, pain, or redness persist or worsen Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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