FDA label 3adfdd2b-9e56-4be2-8ae1-f8cf1a5a2c63

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: 5a64edc5-abf9-44eb-9ede-2a837adefbe5
SPL ID: 3adfdd2b-9e56-4be2-8ae1-f8cf1a5a2c63
Version: 2
Effective date: 2014-08-19
Source export date: 2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:36:54

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		3adfdd2b-9e56-4be2-8ae1-f8cf1a5a2c63	id
spl set id		5a64edc5-abf9-44eb-9ede-2a837adefbe5	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 Warnings: If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If symptoms persist or worsen, a healthcare professional should be consulted. Do not use if you have bloody or black stool. Stop use and ask a doctor if symptoms get worse or diarrhea lasts more than 2 days, have a fever, or have mucus in the stool. Drink plenty of clear fluids to help prevent dehydration caused by diarrhea. Do not use if known sensitivity to Diarrhea or any of its ingredients exists.

Reported adverse events (FAERS/openFDA)#

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