FDA label d43e91f2-5c3a-e863-e053-2a95a90ad82c

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
f27eeb68-63dc-4745-8070-0318dc17d370
SPL ID
d43e91f2-5c3a-e863-e053-2a95a90ad82c
Version
4
Effective date
2021-12-28
Source export date
2026-11-06
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/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:49:57

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 For external use only. Do not use if tube seal is broken or missing. If symptoms persist for more than 7 days or worsen, contact a licensed health care provider. Keep this and all medications out of the reach of children. In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Reported adverse events (FAERS/openFDA)#

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