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 and 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 and Simethicone
- Generic name
- LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
- Manufacturer
- Granules India Ltd
- Product type
- HUMAN OTC DRUG
- SPL set ID
- e0c1693e-0e55-4368-a8a5-2f0882fbf952
- SPL ID
- 44e3c6ff-dda8-ee9e-e063-6394a90a03bb
- Version
- 3
- Effective date
- 2025-12-01
- Source export date
- 2026-09-28
- 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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:19:37
| 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 | 215981 | derived:openfda.application_number |
| application number | ANDA215981 | openfda.application_number | |
| brand name | Loperamide Hydrochloride and Simethicone | openfda.brand_name | |
| generic name | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | openfda.generic_name | |
| manufacturer name | Granules India Ltd | openfda.manufacturer_name | |
| ndc | package | 62207-739-69 | openfda.package_ndc |
| ndc | product | 62207-739 | openfda.product_ndc |
| ndc11 | package | 62207073969 | derived:openfda.package_ndc |
| rxcui | 978001 | openfda.rxcui | |
| spl id | 44e3c6ff-dda8-ee9e-e063-6394a90a03bb | id | |
| spl set id | e0c1693e-0e55-4368-a8a5-2f0882fbf952 | 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.