Active Ingredient (In Each Capsule)
Loperamide HCI 2 mg
Anti-diarrheal Capsule, Liquid Filled
FDA Label NDC 80136-851
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Northeast Pharma for the product Anti-diarrheal (NDC 80136-851). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
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
- in children under 12 years of age
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.
Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea.
- not for use in children under 12 years of age
- adults and children 12 years and over: 2 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours
Other Information
- store at 20°-25°C (68°-77°F). Protect from Light.
- avoid excessive heat above 40°C (104°F)
- do not use if carton or blister unit is open or torn
- see side panel for lot number and expiration date
Inactive Ingredients
butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water
Questions Or Comments?
call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
Distributed by:
NORTHEAST PHARMA
South Burlington, VT 05403
www.heartlandpharmaco.com
1-800-383-0648
L0000440
Rev # 11/19
†This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Imodium ® A-D.
THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Principal Display Panel
NDC 80136-851-42
Heartland Pharma Co.
ANTI-DIARRHEAL
Loperamide HCl Capsules, 2 mg
Controls the Symptoms
of Diarrhea
Suitable for adults and
children 12 years and over
actual size
Compare to active ingredient in Imodium ® A-D †
24 Softgels*
*soft gelatin liquid filled capsules
each softgel contains 2 mg loperamide HCl
12's Carton (12c Image0001v3) 
* Please review the disclaimer below.
