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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
Kroger Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
4
Packages
8
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
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
Skin Barrier Activity [PE] PE 5 members — no class page

Regulatory status

Source: Drugs@FDANDC 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 20260904). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260904 HUMAN OTC DRUG · 20260302 HUMAN OTC DRUG · 20240723

Indications and Usage

openFDA Drug Labeling

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

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 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 • 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 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
37808-714-53 37808-714 H E B 12 BLISTER PACK in 1 CARTON (37808-714-53) / 1 TABLET in 1 BLISTER PACK November 15, 2018
37808-714-62 37808-714 H E B 24 BLISTER PACK in 1 CARTON (37808-714-62) / 1 TABLET in 1 BLISTER PACK February 3, 2020
42507-699-53 42507-699 HyVee Inc 12 BLISTER PACK in 1 CARTON (42507-699-53) / 1 TABLET in 1 BLISTER PACK February 25, 2026
42507-699-62 42507-699 HyVee Inc 24 BLISTER PACK in 1 CARTON (42507-699-62) / 1 TABLET in 1 BLISTER PACK February 25, 2026
30142-581-53 30142-581 Kroger Company 12 BLISTER PACK in 1 CARTON (30142-581-53) / 1 TABLET in 1 BLISTER PACK April 24, 2019
30142-581-62 30142-581 Kroger Company 24 BLISTER PACK in 1 CARTON (30142-581-62) / 1 TABLET in 1 BLISTER PACK February 7, 2020
11822-1003-2 11822-1003 Rite Aid Corporation 12 BLISTER PACK in 1 CARTON (11822-1003-2) / 1 TABLET in 1 BLISTER PACK January 3, 2019
11822-1003-3 11822-1003 Rite Aid Corporation 24 BLISTER PACK in 1 CARTON (11822-1003-3) / 1 TABLET in 1 BLISTER PACK February 24, 2020
37808-714 37808-714 H E B — November 15, 2018
42507-699 42507-699 HyVee Inc — February 25, 2026
30142-581 30142-581 Kroger Company — April 24, 2019
11822-1003 11822-1003 Rite Aid Corporation — January 3, 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.