FDA label 0cde7ea1-af76-a447-e063-6394a90ada20

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
da7c01ac-df65-43a7-b62a-f0e8ab5f8139
SPL ID
0cde7ea1-af76-a447-e063-6394a90ada20
Version
5
Effective date
2023-12-19
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:45:46

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. • 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.