Drugplain

Anti-Diarrheal 2 mg/1

LOPERAMIDE HYDROCHLORIDE · CAPSULE, LIQUID FILLED · TOP CARE (Topco Associates LLC)

2 Recalls on Record
Plain English

Anti-Diarrheal is a capsule, liquid filled containing loperamide hydrochloride at 2 mg/1, taken oral. Manufactured by TOP CARE (Topco Associates LLC).

Key Facts

Brand Name
Anti-Diarrheal
Generic Name
LOPERAMIDE HYDROCHLORIDE
NDC Code (Product)
36800-208
Manufacturer
TOP CARE (Topco Associates LLC)
Strength
2 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
NDA021855
Marketing Start
07/02/2021

Recall History

2 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class III12/26/2018

Sun Pharmaceutical Industries, Inc.

Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

diarrhoea1,704 reports
drug ineffective1,393 reports
off label use1,033 reports
nausea1,016 reports
intentional product use issue868 reports
fatigue799 reports
constipation631 reports
vomiting624 reports
pyrexia582 reports
abdominal pain517 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

Dosage & Administration

Directions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use if you have bloody or black stool 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. 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)

Frequently Asked Questions

What is Anti-Diarrheal used for?

Anti-Diarrheal contains LOPERAMIDE HYDROCHLORIDE. It is a capsule, liquid filled taken oral. Consult your doctor for specific uses.

Is Anti-Diarrheal a controlled substance?

Anti-Diarrheal is not classified as a controlled substance by the DEA.

What is the generic name for Anti-Diarrheal?

The generic name for Anti-Diarrheal is LOPERAMIDE HYDROCHLORIDE. There are 8 other brand versions of LOPERAMIDE HYDROCHLORIDE.

What is the NDC code for Anti-Diarrheal 2 mg/1?

The NDC (National Drug Code) for Anti-Diarrheal 2 mg/1 is 36800-208, listed by TOP CARE (Topco Associates LLC).

Product NDC

36800-208

Package NDC

36800-208-12

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)