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
Loperamide Hydrochloride, Simethicone
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
- Brand name
- Loperamide Hydrochloride, Simethicone
- Generic name
- LOPERAMIDE HYDROCHLORIDE, SIMETHICONE
- Manufacturer
- Guardian Drug Company
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 1b79204e-8a99-455b-84d6-f381fd7d1135
- SPL ID
- 289e6064-8eb8-4b56-bc9e-ee82ad83674f
- Version
- 2
- Effective date
- 2021-06-01
- Source export date
- 2026-10-30
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 19:29:27
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 214541 | derived:openfda.application_number |
| application number | ANDA214541 | openfda.application_number | |
| brand name | Loperamide Hydrochloride, Simethicone | openfda.brand_name | |
| generic name | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | openfda.generic_name | |
| manufacturer name | Guardian Drug Company | openfda.manufacturer_name | |
| ndc | package | 53041-263-50 | openfda.package_ndc |
| ndc | product | 53041-263 | openfda.product_ndc |
| ndc11 | package | 53041026350 | derived:openfda.package_ndc |
| rxcui | 978001 | openfda.rxcui | |
| spl id | 289e6064-8eb8-4b56-bc9e-ee82ad83674f | id | |
| spl set id | 1b79204e-8a99-455b-84d6-f381fd7d1135 | set_id | |
| unii | 77TI35393C | openfda.unii | |
| unii | 92RU3N3Y1O | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.