FDA label d43d4c34-dfbb-7b33-e053-2995a90a56f7

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: 1cc90693-bad9-478e-8e06-db720604dd8a
SPL ID: d43d4c34-dfbb-7b33-e053-2995a90a56f7
Version: 3
Effective date: 2021-12-28
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:22:48

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		d43d4c34-dfbb-7b33-e053-2995a90a56f7	id
spl set id		1cc90693-bad9-478e-8e06-db720604dd8a	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 Ask a doctor before use if pregnant under 3 years of age diarrhea is accompanied by a high fever (greater than 101 °F) blood is present in the stool If symptoms persist for more than two days or worsen, contact a licensed health care professional. Keep this and all medications out of the reach of children. Do not use if imprinted tamper band is broken or missing. In case of accidental overdose, contact a poison control center immediately. In case of emergency, the manufacturer may be contacted 24 hours a day, 7 days a week at 800/624-9659.

Reported adverse events (FAERS/openFDA)#

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