Private Label Distributor

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)

Brand name
Private Label Distributor
Generic name
LOPERAMIDE HCL 2 MG
Manufacturer
Unifirst First Aid Corporation
Product type
HUMAN OTC DRUG
SPL set ID
069e7979-a223-4819-b6cf-ea2731bf156b
SPL ID
441e7620-28e5-8cc5-e063-6394a90a2a72
Version
22
Effective date
2025-12-01
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:46:28
Harmonized routes table
Harmonized routes
ORAL

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 Do not use if you have bloody or black stool Ask a doctor before use if you have a fever mucus in stool a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics 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 more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If you are pregnant or breast feeding , ask a health professional before use. Keep this and all drugs out of the reach of children . In case of accidental overdose, contact a physician or Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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