Active Ingredient (In Each Caplet)
Loperamide HCl 2 mg
Anti-diarrheal Tablet
FDA Label NDC 84441-711
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Imo-gen Labs Llc for the product Anti-diarrheal (NDC 84441-711). 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 caplet), purpose, use, warnings, do not use:, ask a doctor before use if you have:, ask a doctor 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.
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 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 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 (1-800-222-1222) right away.
Directions
- drink plenty of clear liquid to help prevent dehydration caused by diarrhea
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and over | 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours |
| children 9-11 years (60-95 lbs) | 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours |
| children 6-8 years (48-59 lbs) | 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours |
| children 2-5 years (34-47 lbs) | ask a doctor |
| children under 2 years (up to 33 lbs) | do not use |
Other Information
- store between 20° and 25°C (68° and 77°F)
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue, magnesium stearate, microcrystalline cellulose, silica gel
Questions?
call toll-free 1-866-933-6337
Principal Display Panel
Compare to the active ingredient in Imodium ®A-D †
Anti-Diarrheal
Loperamide Hydrocholoride Caplets, 2 mg
Controls Symptoms of Diarrhea
†This product is not manufactured or distributed by the owner of the registered trademark Imodium ®A-D.
Label (Label)
* Please review the disclaimer below.
