FDA.reportPublic FDA data

FDA label 7b2f1a49-488f-031a-e053-2a91aa0aec6c

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
9eeefae2-4163-4cbd-9d17-9175233718ce
SPL ID
7b2f1a49-488f-031a-e053-2a91aa0aec6c
Version
3
Effective date
2018-11-21
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:31:16

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 Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urinating due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives tranquilizers When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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 overdose, get medical help or contact a Poison Control Center.