FDA label 888a2078-444f-498c-bea5-641de87fd094

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: e78c7e0c-2399-4e8a-9687-183b00e5b333
SPL ID: 888a2078-444f-498c-bea5-641de87fd094
Version: 3
Effective date: 2021-10-15
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:05:17

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		888a2078-444f-498c-bea5-641de87fd094	id
spl set id		e78c7e0c-2399-4e8a-9687-183b00e5b333	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 When using this product use only as directed by physician may cause excitability especially in children may cause marked drowsiness; alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery

Reported adverse events (FAERS/openFDA)#

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