FDA label ab41a5fa-67fb-4af3-9ec0-55d8cf51e2d6

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
35827d82-5b6e-493e-b827-4204d9ddc07b
SPL ID
ab41a5fa-67fb-4af3-9ec0-55d8cf51e2d6
Version
5
Effective date
2023-09-29
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:45

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 Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use if you have bloody or black stool Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm 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 tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. 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, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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