FDA.reportPublic FDA data

FDA label 413b17dc-46fd-7a0b-e063-6294a90a9ea6

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
6ac64478-7fb8-4cac-e053-2991aa0a9db0
SPL ID
413b17dc-46fd-7a0b-e063-6294a90a9ea6
Version
3
Effective date
2025-10-15
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:15:41

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 As with any drug, ask a doctor before use if pregnant or breast-feeding. Do not use:  • more than directed.  • if you have a known allergy to any ingredient in this product. Consult a physician if symptoms persist for more than 7 days or worsen. Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately. Do not use if imprinted tamper-evident bottle sleeve is broken or missing. In case of emergency In case of emergency, contact a medical professional or Poison Control Center immediately. Doctor Wise by Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.