Active Ingredient (In Each Caplet)
Loperamide HCl, USP 2 mg
Anti-diarrheal, Circle K Tablet
FDA Label NDC 66715-5529
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, Circle K (NDC 66715-5529). 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 caplet), purpose, use, allergy alert, heart alert, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, 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.
Otc - Do Not Use
Do not use if you have bloody or black stool
Otc - Ask Doctor
Ask a doctor before use if you have
■ fever
■ mucus in the stool
■ a history of liver disease
■ a history of abnormal heart rhythm
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription
drug. Loperamide may interact with certain prescription drugs.
Otc - When Using
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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 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
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?
Questions or comments?
call toll-free
1-877-507-6516 (M-F 8AM - 4:30PM CST)
Pdp [Circle K Anti-Diarrheal, 2Mg Loperamide]
CONTROLS THE SYMPTOMS OF DIARRHEA
Compare to the active ingredient in
Imodium® A-D*
CIRCLE K ™
antidiarrheal
Loperamide HCI
Tablets, USP
2 mg
[caplet image]
actual size
4 caplets** (2 per pouch)
* Please review the disclaimer below.
