FDA label f4e0e896-ebb1-48a0-ae2d-5fb3f523b334

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
45530af0-91f6-4ef2-8faa-200ba6082eb8
SPL ID
f4e0e896-ebb1-48a0-ae2d-5fb3f523b334
Version
2
Effective date
2021-12-23
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:09:45

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 imprinted with Colic Calm logo 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 temporarily, harmless, darkening of the stool may occur. • May stain fabric; protect clothing and furniture.

Reported adverse events (FAERS/openFDA)#

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