FDA label 1109f809-f48b-4e0d-80a3-d786a6fd5723

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
9b50cae4-e10d-40d1-bad2-d8b53aee74fd
SPL ID
1109f809-f48b-4e0d-80a3-d786a6fd5723
Version
5
Effective date
2020-11-02
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 06:02:04

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

Do not use • for children under 12 years of age unless unless directed by a physician • for frequent or prolonged use except under the advice of a physician Ask a doctor before use if you have breathing problems such as emphysema, asthma or pulmonary disease glaucoma if you are taking sedatives or tranquilizers When using this product drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect consult with your physician avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery Do not exceed recommended dosage If preganant or breast-feeding, ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away Other information store at room temperature 59-86 degrees F (15-30 degreesC) tamper-evident sealed packets do not use any opened or torn packets

Reported adverse events (FAERS/openFDA)#

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