FDA label b43d643e-eb36-b295-e053-2995a90a7b6f

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
91d2ec38-7ea2-2b3a-e053-2a95a90af3fd
SPL ID
b43d643e-eb36-b295-e053-2995a90a7b6f
Version
2
Effective date
2020-11-16
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:21:14

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

Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostrate gland Ask a doctor or a pharmacist before use if you sre taking sedatives or tranquilzers When using this product excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating a machinery alcohol, sedatives, and tranquilizers may increase drowsiness If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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