FDA label c2b2accb-cba6-36b5-e053-2995a90a9028

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
b6c40027-cfbd-bff8-e053-2a95a90aeca9
SPL ID
c2b2accb-cba6-36b5-e053-2995a90a9028
Version
2
Effective date
2021-05-19
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 05:22:30

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 temporary harmless darkening of stool may occur. May stain fabric; take care to 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.