Active Ingredient(S)
(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg
Loperamide Hydrochloride And Simethicone Tablet
FDA Label NDC 84441-713
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Imo-gen Labs Llc for the product Loperamide Hydrochloride And Simethicone (NDC 84441-713). 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), purposes, use(s), warnings, heart alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Anti-diarrheal
Anti-gas
Use(S)
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Warnings
Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride
Heart Alert
Taking more than directed can cause serious heart problems or death.
Do Not Use
• if you have bloody or black stool
• if you have difficulty swallowing
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.
• you have difficulty swallowing the tablet
If pregnant or breast-feeding, ask a health professional before use.
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
• take only on an empty stomach (1 hour before or 2 hours after a meal)
• take with a full (8 oz.) glass of water
• find right dose on chart below. 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; 1/2 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; 1/2 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
• each tablet contains:
calcium 640 mg, very low sodium and potassium 5.838 mg
• store between 20 to 25°C (68 to 77°F). Protect from light.
• do not use if carton is open or if blister unit is open or torn
Inactive Ingredients
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
Package Label.Principal Display Panel
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg
Ibs-10 Label (Ibs 10)
* Please review the disclaimer below.
