FDA label 3511206f-0b4f-4ee9-ae76-3c25a25bf2eb

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: 7f9b8aa6-922d-4e45-b7e2-56eef4c80b22
SPL ID: 3511206f-0b4f-4ee9-ae76-3c25a25bf2eb
Version: 2
Effective date: 2016-12-15
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:20:37

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		3511206f-0b4f-4ee9-ae76-3c25a25bf2eb	id
spl set id		7f9b8aa6-922d-4e45-b7e2-56eef4c80b22	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 Tummy Calm logo on 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 temporary, 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.