Active Ingredient (In Each Caplet)
Loperamide HCl 2 mg
Anti-diarrheal Tablet
FDA Label NDC 11822-0375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Anti-diarrheal (NDC 11822-0375). 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 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.
Ask A Doctor Before Use If You Have
- a fever
- mucus in the stool
- a history of liver disease
Ask A Doctor Or Pharmacist Before Use If You Are
taking antibiotics.
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 (1-800-222-1222) right away.
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.
| 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 under 6 years (up to 47 lbs) | ask a doctor |
Other Information
- store between 20°-25°C (68°-77°F)
- see end flap for expiration date and lot number
- do not use if carton or safety seal is broken or missing
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide
Questions Or Comments?
Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
RITE
AID®
PHARMACY
*Compare to the active ingredient in Imodium® A-D
anti-diarrheal
loperamide HCl tablets, 2 mg
anti-diarrheal
for the control of the
symptoms of diarrhea
easy to swallow
200 CAPLETS ACTUAL SIZE
capsule-shaped tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Imodium® A-D.
50844 REV0417B37506
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
SATISFACTION
RITE AID®
GUARANTEE
IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.
* Please review the disclaimer below.
