FDA label 5c51d2c8-89bf-a299-e053-2991aa0a1e2f

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: e5a07b4b-e53d-489f-b7f7-a4e45dbd2152
SPL ID: 5c51d2c8-89bf-a299-e053-2991aa0a1e2f
Version: 4
Effective date: 2017-10-24
Source export date: 2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:11:05

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		5c51d2c8-89bf-a299-e053-2991aa0a1e2f	id
spl set id		e5a07b4b-e53d-489f-b7f7-a4e45dbd2152	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 often than directed for more than 7 days in a row unless directed by doctor or dentist if your child has a known allergy to any ingredient in this product Stop use and ask a doctor if: symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persist or worsen Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.