FDA label 0cce708a-2111-53e4-e063-6294a90a9128

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
ecb2c6a5-bf22-4a05-9a3c-b3d7d4df792f
SPL ID
0cce708a-2111-53e4-e063-6294a90a9128
Version
6
Effective date
2023-12-18
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:37:11

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 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. • As our product is black, a temporarily, 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.