Anti-Diarrheal

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: Anti-Diarrheal
Generic name: LOPERAMIDE HCL
Manufacturer: First Aid Direct
Product type: HUMAN OTC DRUG
SPL set ID: 952fa976-ac4c-4dfb-b689-12c5242498ac
SPL ID: 1588de6a-189b-456d-9569-00332627fa50
Version: 2
Effective date: 2019-09-19
Source export date: 2026-10-23
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/2026-10-23/e2a780351c9d52ec13a8c93757e95e68824c68ebed04761d4eea108c6b76cf54/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 003b0607e7bf4d3ce17ccc0942e221303b4f62b17a6a00c54547eda454293380
Import run: 20261026T035824Z
Imported at: 2026-10-26 04:27:27

Harmonized routes table
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.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	076497	derived:openfda.application_number
application number		ANDA076497	openfda.application_number
brand name		Anti-Diarrheal	openfda.brand_name
generic name		LOPERAMIDE HCL	openfda.generic_name
manufacturer name		First Aid Direct	openfda.manufacturer_name
ndc	package	53117-248-86	openfda.package_ndc
ndc	product	53117-248	openfda.product_ndc
ndc11	package	53117024886	derived:openfda.package_ndc
rxcui		978010	openfda.rxcui
spl id		1588de6a-189b-456d-9569-00332627fa50	id
spl set id		952fa976-ac4c-4dfb-b689-12c5242498ac	set_id
unii		77TI35393C	openfda.unii

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 reactions to Loperamide HCl. Heart alert: Taking more than directed can cause serious heart problems or death. Do not use if you have bloody or black stool Ask a doctor before use if you have fever mucus in the 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 for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast feeding, If pregnant or breast feeding , ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) .

Reported adverse events (FAERS/openFDA)#

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