Loperamide Hydrochloride and Simethicone

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Loperamide Hydrochloride and Simethicone
Generic name
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Manufacturer
IMO-GEN LABS LLC
Product type
HUMAN OTC DRUG
SPL set ID
41d6dba5-e411-c8d2-e063-6294a90ae8fa
SPL ID
41d6dba5-e412-c8d2-e063-6294a90ae8fa
Version
1
Effective date
2025-10-23
Source export date
2026-08-01
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/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:04:19
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride HEART ALERT Taking more than directed can cause serious heart problems or death. DO NOT USE • if you have bloody or black stool • if you have difficulty swallowing 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. • you have difficulty swallowing the tablet If pregnant or breast-feeding , ask a health professional before use. 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)

warnings

HEART ALERT Taking more than directed can cause serious heart problems or death.