Active Ingredient(S)
Active ingredient (in each tablet)
Loperamide HCl USP, 2 mg
Loperamide Hydrochloride 2mg Tablet
FDA Label NDC 25000-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Loperamide Hydrochloride 2mg (NDC 25000-001). 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, ask a doctor or pharmacist before use if, 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
Purpose
Anti-diarrheal
Use(S)
Use controls symptoms of diarrhea, including Travelers' Diarrhea
Warnings
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
Do not use if you have bloody or black stool
Ask A Doctor Before Use If
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
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
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop Use And Ask Doctor If
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
If pregnant or breast-feeding, ask a health professional before use.
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
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 |
Storage
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
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?
Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
Manufactured for: Time-Cap Labs, Inc.
7 Michael Avenue, Farmingdale, NY 11735
Manufactured by: Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa-403722
MADE IN INDIA
Principal Display Panel
NDC: 25000-001-83
Loperamide Hydrochloride Tablets USP, 2mg
24's count blister carton
Loperamide-hcl-tablets-24ct-blister-carton (Loperamide HCl Tablets 24ct Blister Carton)
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