Active Ingredient(In Each Caplet)
Loperamide HCl 2mg
First Aid Direct Anti-diarrheal Capsule
FDA Label NDC 42961-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corp for the product First Aid Direct Anti-diarrheal (NDC 42961-103). 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, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, 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
Otc - Do Not Use
Do not use if you have bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
- fever
- mucus in the stool
- a history of liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking antibiotics
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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
- store at 20°-25°C (68°-77°F)
- avoid excessive heat above 40°C (104°F)
- do not use blister unit is broken or torn
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
Package Label.Principal Display Panel
Image Description (Label 1)
Loperamide Hydrochloride Tablets, 2 mg
Anti-Diarrheal
Controls the Symptoms of Diarrhea
*Compare to active ingredient of Imodium A-D®
DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN
Actual size
12 CAPLETS** Anti-Diarrheal
**Capsule-Shaped Tablets
Image Description (Label 2)
Image Description (Label 2)
Image Description (Label 1)
Manufactured for: fad first aid direct
Mason OH 45040
Product#119250 (1/19)
* Please review the disclaimer below.
