FDA.reportPublic FDA data

FDA label 96932453-80c3-4a44-e053-2a95a90a7bb6

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
96932453-80c2-4a44-e053-2a95a90a7bb6
SPL ID
96932453-80c3-4a44-e053-2a95a90a7bb6
Version
1
Effective date
2019-11-04
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:38

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

WARNING Do not take if -you have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. This medicine contains lactose (sugar) carbohydrates. -you are under 5 Ask doctor before taking if - you are on other medication - you are hypersensitive or have history of allergic response to Tartazine Keep the proper usage and volume Stop use and ask a doctor if - If there is no improvement in the irradiation after 2 weeks of taking the medicine

Reported adverse events (FAERS/openFDA)#

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