FDA label 45731244-8db0-a026-e063-6294a90af69e

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
0fa9a21e-f0d8-4596-9e72-0d69207292a2
SPL ID
45731244-8db0-a026-e063-6294a90af69e
Version
4
Effective date
2025-12-08
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:44

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 if outer seal on glass bottle or protective wrap on oral dispenser is broken or missing. • Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever, or infection occurs. • As with all medications, it is important to ensure that your child's medical professional is aware of the use of this product. • Because product is black, a temporary, harmless, darkening of the stool may occur. • May stain fabric; protect clothing and furniture. • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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