FDA label d436b03f-4329-0865-e053-2995a90a13f6

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
7cb41c28-fbf6-4d0f-8638-5fa514632be7
SPL ID
d436b03f-4329-0865-e053-2995a90a13f6
Version
5
Effective date
2021-12-28
Source export date
2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:17

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. 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. Do not use if imprinted tampered-evident bottle cap band is broken or missing. In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergecy 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.