FDA label d39e01a2-1b76-a8ab-e053-2995a90a1ed4

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: da863695-c4ad-45cb-b98b-7e61077cfc93
SPL ID: d39e01a2-1b76-a8ab-e053-2995a90a1ed4
Version: 6
Effective date: 2021-12-20
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:31:14

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		d39e01a2-1b76-a8ab-e053-2995a90a1ed4	id
spl set id		da863695-c4ad-45cb-b98b-7e61077cfc93	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 to treat food allergies. As with any drug, ask a doctor before use if pregnant or breast-feeding. 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 a 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.