FDA label 08137c31-9f9d-de51-e063-6294a90ab890

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: 641a1680-b671-73fb-e053-2a91aa0a208f
SPL ID: 08137c31-9f9d-de51-e063-6294a90ab890
Version: 3
Effective date: 2023-10-19
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:29:05

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		08137c31-9f9d-de51-e063-6294a90ab890	id
spl set id		641a1680-b671-73fb-e053-2a91aa0a208f	set_id

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 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 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.