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Loperamide Hydrochloride and Simethicone

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
Loperamide Hydrochloride and Simethicone
Generic name
Loperamide Hydrochloride and Simethicone
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
15
Packages
29
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
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
44

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
211059
Application type
ANDA · Abbreviated New Drug Application
Approval date
December 14, 2020
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
1
Products approved under application 211059.
Product Trade name Form Strength Ingredient Status TE Flags
211059-001 LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET LOPERAMIDE HYDROCHLORIDE; SIMETHICONE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 211059.
Type No. Action Status Date Review
Original application 1 Approved December 14, 2020 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251201). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251201 HUMAN OTC DRUG · 20251023

Indications and Usage

openFDA Drug Labeling

USE(S) 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 ag 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 Other information each caplet contains: calcium 148.40 mg, sodium 1.40 mg store between 20-25°C (68-77°F). Protect from light. for blister: do not use if blister unit is torn or broken

WARNINGS Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride 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 tablet If pregnant or breast-feeding , ask a health professional before use. 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)

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

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 tablet If pregnant or breast-feeding , ask a health professional before use.

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENT(S) (in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 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
59651-149-22 59651-149 Aurobindo Pharma Limited 2000 TABLET in 1 BAG (59651-149-22) December 14, 2020
58602-815-74 58602-815 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-815-74) / 6 TABLET in 1 BLISTER PACK December 14, 2020
58602-815-75 58602-815 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-815-75) / 6 TABLET in 1 BLISTER PACK December 14, 2020
58602-815-76 58602-815 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-815-76) / 6 TABLET in 1 BLISTER PACK December 14, 2020
58602-815-80 58602-815 Aurohealth LLC 3 BLISTER PACK in 1 CARTON (58602-815-80) / 6 TABLET in 1 BLISTER PACK December 14, 2020
58602-868-76 58602-868 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK February 24, 2021
58602-869-76 58602-869 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-869-76) / 6 TABLET in 1 BLISTER PACK February 24, 2021
58602-869-80 58602-869 Aurohealth LLC 3 BLISTER PACK in 1 CARTON (58602-869-80) / 6 TABLET in 1 BLISTER PACK May 16, 2021
21130-222-24 21130-222 Better Living Brands, LLC 4 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACK July 21, 2023
21130-222-76 21130-222 Better Living Brands, LLC 3 BLISTER PACK in 1 CARTON (21130-222-76) / 6 TABLET in 1 BLISTER PACK July 21, 2023
69452-210-04 69452-210 Bionpharma Inc. 1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK December 19, 2021
69452-210-12 69452-210 Bionpharma Inc. 4 BLISTER PACK in 1 CARTON (69452-210-12) / 6 TABLET in 1 BLISTER PACK December 19, 2021
69452-531-12 69452-531 Bionpharma Inc. 4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK January 7, 2026
69230-325-00 69230-325 Camber Consumer Care Inc 10 POUCH in 1 DRUM (69230-325-00) / 1000 TABLET in 1 POUCH June 17, 2021
69230-325-04 69230-325 Camber Consumer Care Inc 1 BLISTER PACK in 1 CARTON (69230-325-04) / 4 TABLET in 1 BLISTER PACK June 17, 2021
69230-325-06 69230-325 Camber Consumer Care Inc 1 BLISTER PACK in 1 CARTON (69230-325-06) / 6 TABLET in 1 BLISTER PACK June 17, 2021
69230-325-08 69230-325 Camber Consumer Care Inc 2 BLISTER PACK in 1 CARTON (69230-325-08) / 4 TABLET in 1 BLISTER PACK June 17, 2021
69230-325-12 69230-325 Camber Consumer Care Inc 2 BLISTER PACK in 1 CARTON (69230-325-12) / 6 TABLET in 1 BLISTER PACK June 17, 2021
69230-325-18 69230-325 Camber Consumer Care Inc 3 BLISTER PACK in 1 CARTON (69230-325-18) / 6 TABLET in 1 BLISTER PACK June 17, 2021
69230-325-24 69230-325 Camber Consumer Care Inc 4 BLISTER PACK in 1 CARTON (69230-325-24) / 6 TABLET in 1 BLISTER PACK June 17, 2021
81522-325-24 81522-325 FSA store INC 4 BLISTER PACK in 1 CARTON (81522-325-24) / 6 TABLET in 1 BLISTER PACK June 30, 2024
55319-052-75 55319-052 Family Dollar Stores, LLC 2 BLISTER PACK in 1 CARTON (55319-052-75) / 6 TABLET in 1 BLISTER PACK August 11, 2023
62207-739-69 62207-739 Granules India Ltd 2 BLISTER PACK in 1 CARTON (62207-739-69) / 6 TABLET in 1 BLISTER PACK March 1, 2023
84441-713-10 84441-713 IMO-GEN LABS LLC 100 TABLET in 1 BOTTLE (84441-713-10) October 23, 2025
80136-384-24 80136-384 NORTHEAST PHARMA 4 BLISTER PACK in 1 CARTON (80136-384-24) / 6 TABLET in 1 BLISTER PACK October 27, 2021
0363-9606-75 0363-9606 WALGREEN CO. 2 BLISTER PACK in 1 CARTON (0363-9606-75) / 6 TABLET in 1 BLISTER PACK August 3, 2022
0363-9606-76 0363-9606 WALGREEN CO. 4 BLISTER PACK in 1 CARTON (0363-9606-76) / 6 TABLET in 1 BLISTER PACK August 3, 2022
79903-223-12 79903-223 WALMART INC. 2 BLISTER PACK in 1 CARTON (79903-223-12) / 6 TABLET in 1 BLISTER PACK February 17, 2024
79903-223-24 79903-223 WALMART INC. 4 BLISTER PACK in 1 CARTON (79903-223-24) / 6 TABLET in 1 BLISTER PACK February 17, 2024
59651-149 59651-149 Aurobindo Pharma Limited — December 14, 2020
58602-815 58602-815 Aurohealth LLC — December 14, 2020
58602-868 58602-868 Aurohealth LLC — February 24, 2021
58602-869 58602-869 Aurohealth LLC — February 24, 2021
21130-222 21130-222 Better Living Brands, LLC — July 21, 2023
69452-210 69452-210 Bionpharma Inc. — December 1, 2021
69452-531 69452-531 Bionpharma Inc. — January 7, 2026
69230-325 69230-325 Camber Consumer Care Inc — June 17, 2021
81522-325 81522-325 FSA store INC — June 30, 2024
55319-052 55319-052 Family Dollar Stores, LLC — August 11, 2023
62207-739 62207-739 Granules India Ltd — March 1, 2023
84441-713 84441-713 IMO-GEN LABS LLC — October 23, 2025
80136-384 80136-384 NORTHEAST PHARMA — October 27, 2021
0363-9606 0363-9606 WALGREEN CO. — August 3, 2022
79903-223 79903-223 WALMART INC. — February 17, 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 · 10 sections on this page.