FDA label d69472d8-fc2a-6be1-e053-2a95a90ab480

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
b001ba11-f634-29a8-e053-2995a90ab7c6
SPL ID
d69472d8-fc2a-6be1-e053-2a95a90ab480
Version
2
Effective date
2022-01-27
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:38

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 Ask a Doctor before use if you are: experiencing worsening symptoms or if symptoms persist more than 7 days, have a diagnosed heart arrythmia, under 12 yrs. When using this product You may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowziness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use Keep out of reach of chldren. In case of overdose, get medical help or contact posion Control Center right away

Reported adverse events (FAERS/openFDA)#

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