# Loperamide Hydrochloride, Simethicone

NDC: 53041-263
Generic name: Loperamide Hydrochloride, Simethicone
Labeler / Manufacturer: Guardian Drug Company
Product type: HUMAN OTC DRUG
Marketing category: Abbreviated NDA (generic)
Dosage form: TABLET
Routes: ORAL
Marketing started: 20210601

FDA application: ANDA214541

## Active ingredients

- DIMETHICONE: 125 mg/1
- LOPERAMIDE HYDROCHLORIDE: 2 mg/1

## Pharmacological class

—

## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"53041-263"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=53041-263
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1b79204e-8a99-455b-84d6-f381fd7d1135