Active Ingredient (In Each Caplet)
Loperamide HCl 2 mg
Anti-diarrheal Tablet
FDA Label NDC 80513-375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Anti-diarrheal (NDC 80513-375). 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
- 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
- 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
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store between 20°-25°C (68°-77°F)
- see end flap for expiration date and lot number
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 1-800-630-8895 8:30 AM-4:00 PM ET, Monday-Friday
Principal Display Panel
PUREGEN
LABS
Compare to the active ingredient
in Imodium® A-D*
NDC 80513-375-08
ANTI-DIARRHEAL
Loperamide HCl Tablets, 2 mg
Anti-Diarrheal
Controls the symptoms of diarrhea
24 CAPLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
1. To open, tear
at perforations and
remove a section.
2. Use ✄ to cut
through plastic
for caplet.
*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Imodium® A-D.
50844 ORG061937508
Distributed by: ADVANCED RX LLC
1942 NE 163rd St
North Miami Beach, FL 33162 U.S.A.
Puregen 44-375 (Puregen 44 375 1)
* Please review the disclaimer below.
