FDA label 81f218cb-345b-4f3f-8aff-bdc40d0bc9a3

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
d7419e82-55d7-4699-a2d5-c45c54f845c7
SPL ID
81f218cb-345b-4f3f-8aff-bdc40d0bc9a3
Version
3
Effective date
2021-04-15
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 01:26:33

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 Do not use for children under 12 years of age unless directed by a doctor for frequent or prolonged use except under the advice of a doctor Ask a doctor before use if you have breathing problems such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland if you are taking sedatives or tranquilizers When using this product drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery Do not exceed recommended dosage. 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.