FDA label 41b263e2-8b5b-c913-e063-6294a90a82bc

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
58ece525-b626-fa51-e053-2991aa0a35ef
SPL ID
41b263e2-8b5b-c913-e063-6294a90a82bc
Version
6
Effective date
2025-10-21
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:16:38

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 a 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 persists or worsens. Keep this and all medications 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 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.