FDA label 41b26831-c5a8-55fa-e063-6394a90ab6f7

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
58b2bd93-e980-ed15-e053-2991aa0aca03
SPL ID
41b26831-c5a8-55fa-e063-6394a90ab6f7
Version
6
Effective date
2025-10-21
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:43

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

As with any drug, ask doctor before use if pregnant or breast-feeding. Do not use • more than directed • if your child has known allergy to any ingredient in this product. Consult a physician if: • symptoms persist for more than 72 hours or worsen • swelling increases, rash or fever develops • Irritation, pain or redness persist or worsens Keep this and all medication out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately. Do not use if imprinted tamper band is broken or missing. In case of an emergency contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emeregency 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.