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
Anti-Diarrheal/Anti-Gas
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
- Anti-Diarrheal/Anti-Gas
- Generic name
- LOPERAMIDE HYDROCHLORIDE, SIMETHICONE
- Manufacturer
- Discount Drug Mart, Inc
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 2e0b3aec-f436-c0fb-e063-6394a90abb51
- SPL ID
- e44c3937-4a74-46c4-a467-398229e5aece
- Version
- 2
- Effective date
- 2025-02-27
- Source export date
- 2026-11-06
- 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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:54:45
| 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 | Anti-Diarrheal/Anti-Gas | openfda.brand_name | |
| generic name | LOPERAMIDE HYDROCHLORIDE, SIMETHICONE | openfda.generic_name | |
| manufacturer name | Discount Drug Mart, Inc | openfda.manufacturer_name | |
| ndc | package | 53943-263-33 | openfda.package_ndc |
| ndc | product | 53943-263 | openfda.product_ndc |
| ndc11 | package | 53943026333 | derived:openfda.package_ndc |
| rxcui | 978001 | openfda.rxcui | |
| spl id | e44c3937-4a74-46c4-a467-398229e5aece | id | |
| spl set id | 2e0b3aec-f436-c0fb-e063-6394a90abb51 | 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.