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Anti Diarrheal

Loperamide HCl · Tablet

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
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Chain Drug Marketing Association, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
5
Packages
7
Data completeness
82% 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
Route of administration
Oral
Presentations
12

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 20260119). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260119 HUMAN OTC DRUG · 20250203

Indications and Usage

openFDA Drug Labeling

Use 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 reaction 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 a fever mucus in the stool a history of liver disease a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. 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, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 a fever mucus in the stool a history of liver disease a history of abnormal heart rhythm

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 2 mg

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
55301-375-02 55301-375 ARMY AND AIR FORCE EXCHANGE SERVICE 2 BLISTER PACK in 1 CARTON (55301-375-02) / 6 TABLET in 1 BLISTER PACK May 3, 2005
63868-559-12 63868-559 CHAIN DRUG MARKETING ASSOCIATION INC 2 BLISTER PACK in 1 CARTON (63868-559-12) / 6 TABLET in 1 BLISTER PACK May 3, 2005
63868-559-24 63868-559 CHAIN DRUG MARKETING ASSOCIATION INC 4 BLISTER PACK in 1 CARTON (63868-559-24) / 6 TABLET in 1 BLISTER PACK May 3, 2005
83324-064-12 83324-064 Chain Drug Marketing Association, Inc. 2 BLISTER PACK in 1 CARTON (83324-064-12) / 6 TABLET in 1 BLISTER PACK June 17, 2024
83324-064-24 83324-064 Chain Drug Marketing Association, Inc. 4 BLISTER PACK in 1 CARTON (83324-064-24) / 6 TABLET in 1 BLISTER PACK June 17, 2024
49035-375-08 49035-375 Wal-Mart Stores Inc 6 BLISTER PACK in 1 CARTON (49035-375-08) / 4 TABLET in 1 BLISTER PACK (49035-375-38) May 3, 2005
73581-171-24 73581-171 Yyba Corp 4 BLISTER PACK in 1 CARTON (73581-171-24) / 6 TABLET in 1 BLISTER PACK February 21, 2024
55301-375 55301-375 ARMY AND AIR FORCE EXCHANGE SERVICE — May 3, 2005
63868-559 63868-559 CHAIN DRUG MARKETING ASSOCIATION INC — May 3, 2005
83324-064 83324-064 Chain Drug Marketing Association, Inc. — June 17, 2024
49035-375 49035-375 Wal-Mart Stores Inc — May 3, 2005
73581-171 73581-171 Yyba Corp — February 21, 2024

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.