FDA label d57f8c18-dff0-0fd4-e053-2995a90abc70

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: 9ca71d93-2d32-4a74-8a5a-39ef446067e0
SPL ID: d57f8c18-dff0-0fd4-e053-2995a90abc70
Version: 3
Effective date: 2022-01-13
Source export date: 2026-09-28
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:34:11

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		d57f8c18-dff0-0fd4-e053-2995a90abc70	id
spl set id		9ca71d93-2d32-4a74-8a5a-39ef446067e0	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 Ask a doctor before use if you have A breathing problem such as emphysema or chronic bronchitis Glaucoma Trouble urinating due to enlarged prostate gland. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product Excitability may occur, especially in children. May cause drowsiness Avoid alcoholic beverages when taking this product. Alcohol, sedatives and tranquilizers may increase drowsiness effect. Use caution when driving a motor vehicle or operating machinery. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of an 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.