FDA label 82a448ec-d961-4906-b887-7c04bc4dfed5

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: 27f7b52b-4384-4cf2-9723-16c5b610247b
SPL ID: 82a448ec-d961-4906-b887-7c04bc4dfed5
Version: 9
Effective date: 2019-02-28
Source export date: 2026-10-12
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:26:20

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		82a448ec-d961-4906-b887-7c04bc4dfed5	id
spl set id		27f7b52b-4384-4cf2-9723-16c5b610247b	set_id

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 are 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.