Drugplain

Loperamide Hydrochloride 2 mg/1

Loperamide Hydrochloride · CAPSULE, LIQUID FILLED · Dr. Reddy's Laboratories Inc.

1 Recall on Record
Plain English

Loperamide Hydrochloride is a capsule, liquid filled containing loperamide hydrochloride at 2 mg/1, taken oral. Manufactured by Dr. Reddy's Laboratories Inc..

Key Facts

Brand Name
Loperamide Hydrochloride
Generic Name
Loperamide Hydrochloride
NDC Code (Product)
75907-097
Manufacturer
Dr. Reddy's Laboratories Inc.
Strength
2 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
ANDA213070
Marketing Start
10/22/2021

Recall History

1 Recall on Record
Class II04/13/2022

Mckesson Medical-Surgical Inc. Corporate Office

cGMP deviations: Temperature abuse

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

diarrhoea1,611 reports
drug ineffective1,321 reports
off label use990 reports
nausea917 reports
intentional product use issue867 reports
fatigue762 reports
constipation574 reports
pyrexia557 reports
vomiting547 reports
weight decreased470 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 used for?

Loperamide Hydrochloride contains Loperamide Hydrochloride. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Loperamide Hydrochloride a controlled substance?

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

What is the generic name for Loperamide Hydrochloride?

The generic name for Loperamide Hydrochloride is Loperamide Hydrochloride. There are 10 other brand versions of Loperamide Hydrochloride.

What is the NDC code for Loperamide Hydrochloride 2 mg/1?

The NDC (National Drug Code) for Loperamide Hydrochloride 2 mg/1 is 75907-097, listed by Dr. Reddy's Laboratories Inc..