Good Sense Anti Diarrheal Anti Gas

Overview

Brand name

Good Sense Anti Diarrheal Anti Gas

Generic name

loperamide hydrochloride, simethicone

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

L. Perrigo Company

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

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
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

5

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@FDA NDC Directory

Application number

209837

Application type

ANDA · Abbreviated New Drug Application

Approval date

September 5, 2018

Sponsor

PERRIGO R AND D

Products on application

1

Submissions recorded

3

Products approved under application 209837.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
209837-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	TABLET		LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 209837.
Type	No.	Action	Status	Date	Review
Supplement	9	Labeling	Approved	July 9, 2021	Standard
Supplement	4	Labeling	Approved	December 3, 2019	Standard
Original application	1		Approved	September 5, 2018	Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260520). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260520

Indications and Usage

openFDA Drug Labeling

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Purpose

openFDA Drug Labeling

Purposes 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 • if you have bloody or black stool • if you have difficulty swallowing Ask a doctor before use if you have • 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. • you have difficulty swallowing the caplet 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 • if you have difficulty swallowing

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • 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. • 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
0113-0087-53	0113-0087	L. Perrigo Company	12 BLISTER PACK in 1 CARTON (0113-0087-53) / 1 TABLET in 1 BLISTER PACK	October 11, 2018
0113-0087-62	0113-0087	L. Perrigo Company	24 BLISTER PACK in 1 CARTON (0113-0087-62) / 1 TABLET in 1 BLISTER PACK	June 10, 2019
0113-1087-89	0113-1087	L. Perrigo Company	18 BLISTER PACK in 1 CARTON (0113-1087-89) / 1 TABLET in 1 BLISTER PACK	January 29, 2019
0113-0087	0113-0087	L. Perrigo Company	—	October 11, 2018
0113-1087	0113-1087	L. Perrigo Company	—	January 29, 2019

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.