FDA label 0b27aade-f2bb-66f8-e063-6294a90a0fb2

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
4c600c0a-4254-4fe6-8c4c-99095c5412f2
SPL ID
0b27aade-f2bb-66f8-e063-6294a90a0fb2
Version
3
Effective date
2023-11-27
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:02:55

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 have ■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema ■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem such as emphysema or chronic bronchitis Ask a doctor before use if you are taking sedative or tranquilizers When using this product ■ do not use more than directed ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful when driving a motor vehicle or operating machinery ■ excitability may occur, especially in children Stop use and ask a doctor if ■ nervousness, dizziness, or sleeplessness occurs ■ symptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition ■ new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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