FDA label 6025ae3b-4a26-e618-e053-2a91aa0a57ca

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
056b6032-c92d-458e-97d4-a964d1adb38a
SPL ID
6025ae3b-4a26-e618-e053-2a91aa0a57ca
Version
2
Effective date
2017-12-12
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:13:20

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 2 years of age unless directed by a doctor Ask doctor before use if you have •breathing problem such as emphysema or chronic bronchitis •glaucoma •trouble urinatining due to an enlarged prostate gland. Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product •marked drowsiness may occur •avoid alcoholic drinks •alcohol, sedatives and tranquilizers may increase drowsiness •be careful when driving a motor vehicle or operating machinery. If pregnant or breast feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.