Loperamide Hydrochloride and Simethicone

Loperamide Hydrochloride and Simethicone is an FDA-registered drug product whose active ingredient is LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE. It is labelled by Aurohealth LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 58602-868, application ANDA211059, label effective 20260505. It is one of 2 FDA drug label records sharing the active ingredient LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE are most often described in connection with: relieves symptoms, diarrhea plus, bloating pressure, cramps commonly, referred gas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

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 to 11 years (60 to 95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6 to 8 years (48 to 59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2 to 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

FDA lists 2 drug label records with LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Loperamide Hydrochloride and Simethicone used for?
Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Who makes Loperamide Hydrochloride and Simethicone?
Aurohealth LLC is the labeler of record for Loperamide Hydrochloride and Simethicone. 2 FDA label records share the active ingredient LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Loperamide Hydrochloride and Simethicone come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Loperamide Hydrochloride and Simethicone prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE?
Yes. 2 FDA drug label records list LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Loperamide Hydrochloride and Simethicone been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.