FDA label 413b1ede-db07-9849-e063-6294a90a6a01

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: 987988e0-e67e-4d46-b117-5ffa126885ff
SPL ID: 413b1ede-db07-9849-e063-6294a90a6a01
Version: 6
Effective date: 2025-10-15
Source export date: 2026-11-06
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:47:12

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		413b1ede-db07-9849-e063-6294a90a6a01	id
spl set id		987988e0-e67e-4d46-b117-5ffa126885ff	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 As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if: fever develops diarrhea lasts for more than 2 days worsens other 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-evident bottle cap band is broken or missing. The inner packaged bottle is child-resistant. 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.