FDA label 37ee13c7-94d8-c699-e063-6294a90aff26

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
0c51c36a-f955-e176-e063-6394a90a4f8b
SPL ID
37ee13c7-94d8-c699-e063-6294a90aff26
Version
2
Effective date
2025-06-19
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:38

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 Allergy alert Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl. Heart alert Heart alert: Taking more than directed can cause serious heart problems or death. Do not use Do not use if you have bloody or black stool. Ask a doctor Ask a doctor before use if you have a fever mucus in the stool a history of liver disease a history of abnormal heart rhythm Ask a doctor or pharmacist Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. When using this product When using this product , tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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