Drugplain

Loperamide Hydrochloride and Simethicone 125 mg/1

Loperamide Hydrochloride and Simethicone · TABLET · NORTHEAST PHARMA

No Recall History
Plain English

Loperamide Hydrochloride and Simethicone is a tablet containing loperamide hydrochloride and simethicone at 125 mg/1, taken oral. Manufactured by NORTHEAST PHARMA.

Key Facts

Brand Name
Loperamide Hydrochloride and Simethicone
Generic Name
Loperamide Hydrochloride and Simethicone
NDC Code (Product)
80136-384
Manufacturer
NORTHEAST PHARMA
Strength
125 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA211059
Marketing Start
10/27/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea6 reports
fatigue5 reports
cough4 reports
productive cough4 reports
abdominal pain upper3 reports
decreased appetite3 reports
dizziness3 reports
dyspnoea3 reports
headache3 reports
muscle spasms3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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

WARNINGS Allergy alert: Do not use 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

Frequently Asked Questions

What is Loperamide Hydrochloride and Simethicone used for?

Loperamide Hydrochloride and Simethicone contains Loperamide Hydrochloride and Simethicone. It is a tablet taken oral. Consult your doctor for specific uses.

Is Loperamide Hydrochloride and Simethicone a controlled substance?

Loperamide Hydrochloride and Simethicone is not classified as a controlled substance by the DEA.

What is the generic name for Loperamide Hydrochloride and Simethicone?

The generic name for Loperamide Hydrochloride and Simethicone is Loperamide Hydrochloride and Simethicone. There are 1 other brand versions of Loperamide Hydrochloride and Simethicone.

What is the NDC code for Loperamide Hydrochloride and Simethicone 125 mg/1?

The NDC (National Drug Code) for Loperamide Hydrochloride and Simethicone 125 mg/1 is 80136-384, listed by NORTHEAST PHARMA.

Product NDC

80136-384

Package NDC

80136-384-24

Other Loperamide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)