Active Ingredient(S)
Loperamide HCl 2mg
Anti-diarrheal Capsule
FDA Label NDC 68998-248
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Anti-diarrheal (NDC 68998-248). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-Diarrheal
Use(S)
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
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.
Pregnancy/Breastfeeding
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 below. 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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets 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
■ do not use if blister unit is broken or torn
Storage
■ store at room temperature 20°-25°C (68°-77° F)
■ avoid excessive heat above 40°C (104°F)
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
Questions
Call 1-888-952-0050 Monday-Friday 9AM-5PM EST
Principal Display Panel
Anti Diarrheal
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