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Anti-Diarrheal/Anti-Gas

Loperamide Hydrochloride, Simethicone · 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/Anti-Gas
Generic name
Loperamide Hydrochloride, Simethicone
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Discount Drug Mart, Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
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
Dimethicone 125 mg/1 200010 View
Loperamide Hydrochloride 2 mg/1 978006 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
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
Skin Barrier Activity [PE] PE 5 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
214541
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 27, 2021
Sponsor
GUARDIAN DRUG
Products on application
1
Submissions recorded
1
Products approved under application 214541.
Product Trade name Form Strength Ingredient Status TE Flags
214541-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET LOPERAMIDE HYDROCHLORIDE; SIMETHICONE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 214541.
Type No. Action Status Date Review
Original application 1 Approved May 27, 2021 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250205). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250205

Indications and Usage

openFDA Drug Labeling

USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Purpose

openFDA Drug Labeling

PURPOSE Anti-diarrheal Anti-gas

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea take only on an empty stomach (1 hour before or 2 hours after a meal) take with a full (8 oz.) glass of water find right dose on chart below. 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

openFDA Drug Labeling

DO NOT USE if you have bloody or black stool if you have difficulty swallowing

Ask a Doctor

openFDA Drug Labeling

ASK A DOCTOR BEFORE USE IF THE CHILD HAS 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 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. you have difficulty swallowing the caplet

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENTS (in each caplet) Loperamide HCl 2 mg Simethicone 125 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
53943-263-33 53943-263 Discount Drug Mart, Inc 4 BLISTER PACK in 1 CARTON (53943-263-33) / 6 TABLET in 1 BLISTER PACK February 26, 2025
69256-265-31 69256-265 Harris Teeter, LLC 2 BLISTER PACK in 1 CARTON (69256-265-31) / 6 TABLET in 1 BLISTER PACK February 5, 2025
69256-265-33 69256-265 Harris Teeter, LLC 4 BLISTER PACK in 1 CARTON (69256-265-33) / 6 TABLET in 1 BLISTER PACK February 5, 2025
69256-265-73 69256-265 Harris Teeter, LLC 3 BLISTER PACK in 1 CARTON (69256-265-73) / 6 TABLET in 1 BLISTER PACK February 5, 2025
53943-263 53943-263 Discount Drug Mart, Inc — February 26, 2025
69256-265 69256-265 Harris Teeter, LLC — February 5, 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.