FDA label ceb053bd-43c0-44d9-a2e7-add6b295b6d0

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
54731aaf-d413-4976-b040-40c8e3e7eafd
SPL ID
ceb053bd-43c0-44d9-a2e7-add6b295b6d0
Version
6
Effective date
2026-06-12
Source export date
2026-11-06
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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:53:43

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 in children under 12 years of age unless directed by a doctor Ask a doctor before use if you have  glaucoma  a breathing problem such as emphysema or chronic bronchitis  trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product  Do not exceed recommended dosage  may cause drowsiness  alcohol, sedatives, and tranquilizers may increase drowsiness  avoid alcoholic drinks  use caution when driving a motor vehicle or operating machinery 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 (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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