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Anti-Diarrheal

Loperamide HCl · Tablet, Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Anti-Diarrheal
Generic name
Loperamide HCl
Dosage form
Tablet, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
First Aid Direct
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
3
Packages
3
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Loperamide Hydrochloride 2 mg/1 978006 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Opioid Agonist [EPC] EPC All 109 members
Opioid Agonists [MoA] MoA All 35 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076497
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 10, 2003
Sponsor
LNK
Products on application
1
Submissions recorded
3
Products approved under application 076497.
Product Trade name Form Strength Ingredient Status TE Flags
076497-001 LOPERAMIDE HYDROCHLORIDE TABLET LOPERAMIDE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076497.
Type No. Action Status Date Review
Supplement 7 Labeling Approved April 2, 2021 Standard
Supplement 2 Labeling Approved September 9, 2015 —
Original application 1 Approved June 10, 2003 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260319). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260319 HUMAN OTC DRUG · 20190919

Indications and Usage

openFDA Drug Labeling

Use(s) controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

openFDA Drug Labeling

Purpose Anti-diarrheal

Dosage and Administration

openFDA Drug Labeling

Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over: 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs): 1 caplet after the first loose stool; 1⁄2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs): 1 caplet after the first loose stool; 1⁄2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34 to 47 lbs): ask a doctor children under 2 years (up to 33 lbs): do not use

Warnings

openFDA Drug Labeling

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) .

Do Not Use

openFDA Drug Labeling

Do not use if you have bloody or black stool

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have fever mucus in the stool a history of liver disease

Stop Use

openFDA Drug Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active Ingredient (in each caplet) Loperamide HCl 2mg

Adverse event reports

Source: openFDA FAERS
50,038
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LOPERAMIDE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
69168-248-86 69168-248 Allegiant Health 2 BLISTER PACK in 1 CARTON (69168-248-86) / 6 TABLET, COATED in 1 BLISTER PACK May 3, 2005
53117-248-86 53117-248 First Aid Direct 2 BLISTER PACK in 1 CARTON (53117-248-86) / 6 TABLET, COATED in 1 BLISTER PACK May 3, 2005
85828-248-93 85828-248 Grocery Outlet 2 BLISTER PACK in 1 CARTON (85828-248-93) / 12 TABLET, COATED in 1 BLISTER PACK March 19, 2026
69168-248 69168-248 Allegiant Health — May 3, 2005
53117-248 53117-248 First Aid Direct — May 3, 2005
85828-248 85828-248 Grocery Outlet — March 19, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.