Drugplain

anti diarrheal 1 mg/7.5mL

loperamide HCl · SOLUTION · Kroger Company

2 Recalls on Record
Plain English

anti diarrheal is a solution containing loperamide hcl at 1 mg/7.5mL, taken oral. Manufactured by Kroger Company.

Key Facts

Brand Name
anti diarrheal
Generic Name
loperamide HCl
NDC Code (Product)
30142-514
Manufacturer
Kroger Company
Strength
1 mg/7.5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA091292
Marketing Start
06/11/2018

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

diarrhoea1,702 reports
drug ineffective1,393 reports
off label use1,033 reports
nausea1,015 reports
intentional product use issue868 reports
fatigue800 reports
constipation630 reports
vomiting623 reports
pyrexia583 reports
abdominal pain518 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 HCl. It is a solution 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 HCl. There are 10 other brand versions of loperamide HCl.

What is the NDC code for anti diarrheal 1 mg/7.5mL?

The NDC (National Drug Code) for anti diarrheal 1 mg/7.5mL is 30142-514, listed by Kroger Company.