FDA label 1b61e15c-f07f-2304-e063-6394a90a34a5

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
be9d1f8c-f7b8-41fc-8c3f-d471dd6534c8
SPL ID
1b61e15c-f07f-2304-e063-6394a90a34a5
Version
2
Effective date
2024-06-21
Source export date
2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:40:27

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 For oral use only Do not use if you have • glaucoma • difficulty in urination, prostate disease ( risk of ischuria) • billiary atresia • cholelithiasis • liver disease • previously experienced sensitivity to this medication Ask a doctor, dentist, or pharmacist before use if the user takes • other medication • reserpine derivatives • cholagogue Stop use and ask a doctor if • there is no remission of symptoms after several dosages for 2 weeks. Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage. This product contains Sodium Benzoate: it may cause minor irritation on skin, eye, and mucous membrane.

Reported adverse events (FAERS/openFDA)#

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