FDA label c172c75c-5241-44a3-8d8a-b9641bc67245

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
d06bc43c-ac11-4a20-8af8-89aca8934c15
SPL ID
c172c75c-5241-44a3-8d8a-b9641bc67245
Version
6
Effective date
2021-12-23
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:27:27

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: • 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.