FDA label 0812f0c1-ccc4-6586-e063-6394a90a4999

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
5928225b-c63c-acff-e053-2991aa0ae653
SPL ID
0812f0c1-ccc4-6586-e063-6394a90a4999
Version
5
Effective date
2023-10-19
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:29:58

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 you have a known allergy to any ingredient in this product. Consult a physician 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. Tamper Band Safety 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.