Active Ingredient ( In Each Tablet)
Loperamide HCl, USP 2 mg
Anti-diarrheal Tablet
FDA Label NDC 29485-9286
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Anti-diarrheal (NDC 29485-9286). 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 tablet), purpose, use, allergy alert, heart alert, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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
Controls symptoms of diarrhea, including Travelers’ Diarrhea
Allergy Alert
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.
Heart Alert
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 caplets after the first loose stool; 1 caplet after each subsequent loose stool;
|
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;
|
children 2 - 5 years (34 - 47 lbs) | ask a doctor |
children under 2 (up to 33 lbs) | do not use |
Other Information
Other information
■ store between 68-77°F (20-25°C)
Inactive Ingredients
anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow
no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated
vegetable oil, magnesium stearate, powdered cellulose, pregelatinized
starch
Questions Or Comments?
Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)
Other
*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D
Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404
2 Mg Loperamide Tablet
Compare to the active ingredient in Imodium® A-D*
Diamode
Anti-Diarrheal Relief
Loperamide HCl
Tablets, USP 2 mg
[tablet image]
actual size
1 CAPLET IN EACH PACKET
READ DRUG FACTS AND INSTRUCTIONS ON PACKET
* Please review the disclaimer below.
