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MEDIQUE Diamode

Loperamide Hydrochloride · 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
MEDIQUE Diamode
Generic name
Loperamide Hydrochloride
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Unifirst First Aid Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
11
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
Route of administration
Oral
Presentations
15

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
074091
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 10, 1992
Sponsor
OHM LABS
Products on application
1
Submissions recorded
14
Products approved under application 074091.
Product Trade name Form Strength Ingredient Status TE Flags
074091-001 LOPERAMIDE HYDROCHLORIDE TABLET LOPERAMIDE HYDROCHLORIDE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 074091.
Type No. Action Status Date Review
Supplement 34 Labeling Approved July 9, 2021 Standard
Supplement 33 Labeling Approved July 9, 2021 Standard
Supplement 30 Labeling Approved July 9, 2021 Standard
Supplement 36 Labeling Approved September 9, 2020 Standard
Supplement 21 Labeling Approved September 12, 2006 —
Supplement 9 Labeling Approved October 16, 2002 —
Supplement 8 Manufacturing (CMC) Approved January 17, 2002 —
Supplement 5 Labeling Approved December 28, 2000 —
Supplement 7 Manufacturing (CMC) Approved June 21, 2000 —
Supplement 3 Labeling Approved February 27, 1998 —
Supplement 4 Manufacturing (CMC) Approved May 13, 1997 —
Supplement 2 Manufacturing (CMC) Approved July 18, 1994 —
Supplement 1 Labeling Approved June 16, 1993 —
Original application 1 Approved December 10, 1992 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260424). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260424 HUMAN OTC DRUG · 20251001

Indications and Usage

openFDA Drug Labeling

Uses Controls the symptoms of diarrhea, including Travelers diarrhea.

Purpose

openFDA Drug Labeling

Purpose Anti-diarrheal

Dosage and Administration

openFDA Drug Labeling

Directions do not use more than directed drink plenty of clear fluids to help prevent dehydration caused by diarrhea Adults and children (12 years and older): Take 2 caplets after the first loose stool followed by 1 caplet after each subsequent loose stool but no more than 4 caplets in 24 hours. Children under 12 years: Do not give to children under 12 years of age.

Warnings

openFDA Drug Labeling

Warnings Allery 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 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 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 (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 • a 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 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 Hydrochloride 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
71205-316-01 71205-316 Proficient Rx LP 1 TABLET in 1 PACKET (71205-316-01) September 1, 2019
71205-316-06 71205-316 Proficient Rx LP 6 TABLET in 1 PACKET (71205-316-06) October 1, 2019
85766-120-01 85766-120 Sportpharm LLC 1 TABLET in 1 PACKET (85766-120-01) December 12, 2025
85766-120-06 85766-120 Sportpharm LLC 6 PACKET in 1 BOX, UNIT-DOSE (85766-120-06) / 1 TABLET in 1 PACKET December 12, 2025
85766-120-24 85766-120 Sportpharm LLC 24 PACKET in 1 BOX, UNIT-DOSE (85766-120-24) / 1 TABLET in 1 PACKET (85766-120-01) December 12, 2025
47682-200-46 47682-200 Unifirst First Aid Corporation 1 TABLET in 1 PACKET (47682-200-46) December 30, 2008
47682-200-64 47682-200 Unifirst First Aid Corporation 24 PACKET in 1 BOX, UNIT-DOSE (47682-200-64) / 1 TABLET in 1 PACKET (47682-200-46) December 30, 2008
47682-200-69 47682-200 Unifirst First Aid Corporation 6 PACKET in 1 BOX, UNIT-DOSE (47682-200-69) / 1 TABLET in 1 PACKET December 30, 2008
47682-400-46 47682-400 Unifirst First Aid Corporation 1 TABLET in 1 PACKET (47682-400-46) December 1, 2025
47682-400-64 47682-400 Unifirst First Aid Corporation 24 PACKET in 1 BOX, UNIT-DOSE (47682-400-64) / 1 TABLET in 1 PACKET (47682-400-46) December 1, 2025
47682-400-69 47682-400 Unifirst First Aid Corporation 6 PACKET in 1 BOX, UNIT-DOSE (47682-400-69) / 1 TABLET in 1 PACKET (47682-400-46) December 1, 2025
71205-316 71205-316 Proficient Rx LP — December 30, 2008
85766-120 85766-120 Sportpharm LLC — December 30, 2008
47682-200 47682-200 Unifirst First Aid Corporation — December 30, 2008
47682-400 47682-400 Unifirst First Aid Corporation — December 1, 2025

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 · 10 sections on this page.