Anti-diarrheal
a3687b81-1f4d-49d5-a25f-b16560ab83d8
HUMAN OTC DRUG LABEL
May 1, 2025
BI-MART
DUNS: 027630078
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loperamide HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel-100 Caplets
NDC 37835-131-01
Compare to active ingredient in Imodium ®A-D †
ANTI-DIARRHEAL
CAPLETS*
Loperamide HCl Tablets, 2 mg
ANTI-DIARRHEAL
Controls the symptoms of diarrhea
Original Prescription Strength
100 Caplets*
Each caplet (*capsule shaped tablet contains Loperamide HCl, 2 mg)
†This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Imodium ®A-D.
Distributed byBI-MART, Eugene, OR 97402
INDICATIONS & USAGE SECTION
Use
Controls symptoms of diarrhea, including Traveler's Diarrhea
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Loperamide HCl 2 mg
OTC - PURPOSE SECTION
Purpose
Anti-diarrheal
WARNINGS SECTION
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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
*drink plenty of clear liquids 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 |
STORAGE AND HANDLING SECTION
Other information
- do not use if seal around caplet is broken or damaged
- store between 20º and 25ºC (68º and 77ºF)
INACTIVE INGREDIENT SECTION
Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel
OTC - QUESTIONS SECTION
Questions?
Call toll-free1-844-912-4012