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
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:59:05

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.