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Drug Facts
Anti-diarrheal Tablet, Film Coated
FDA Label NDC 41226-797
17 label sections · Submitted to the FDA by Kroger · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger for the product Anti-diarrheal (NDC 41226-797). 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 other, active ingredient (in each tablet), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Loperamide HCl USP, 2 mg
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 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 (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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours |
| children 9-11 years (60-95 lbs) | 1 tablet after the first loose stool; ½ tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours |
| children 6-8 years (48-59 lbs) | 1 tablet after the first loose stool; ½ tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours |
| children 2-5 years (34 to 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)
- do not use if carton or blister unit is open or torn
- FDA approved dissolution test specifications differ from USP
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions Or Comments?
Call 1-800-632-6900
Package Label.Principal Display Panel
Anti-Diarrheal 24 count Carton
Loperamide-24s-carton (Loperamide 24s Carton)
Loperamide-12s-carton (Loperamide 12s Carton)
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