Anti-Diarrheal LOPERAMIDE HCL BETTER LIVING BRANDS, LLC FDA Approved Use controls symptoms of diarrhea, including Travelers' Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA076497
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Loperamide HCl 2 mg
Inactive Ingredients
Inactive ingredients corn starch D&C yellow #10 aluminum lake dibasic calcium phosphate dihydrate FD&C blue #1 aluminum lake magnesium stearate microcrystalline cellulose silicon dioxide
Strengths
2 mg
Quantities
0009 count
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: oval Color: green Imprint: 44;375

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0321130777878
UNII
77TI35393C
Packaging

Principal Display Pane l COMPARE TO Imodium® A-D active ingredient* Signature SELECT ® NDC 21130-375-08 ANTI-DIARRHEAL LOPERAMIDE HCl 2 mg Anti-Diarrheal CONTROLS THE SYMPTOMS OF DIARRHEA Actual Size 24 CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-723-3929 LOVE IT OR IT'S ON US‡ *This product is not manufactured or distributed by Kenvue Inc., distributors of Imodium® A-D. 50844 REV0325Q37508 1. To open, tear at perforations and remove a section. 2. Use ✄ to cut through plastic for caplet. Signature Select 44-375 Signature Select 44-375

Package Descriptions
  • Principal Display Pane l COMPARE TO Imodium® A-D active ingredient* Signature SELECT ® NDC 21130-375-08 ANTI-DIARRHEAL LOPERAMIDE HCl 2 mg Anti-Diarrheal CONTROLS THE SYMPTOMS OF DIARRHEA Actual Size 24 CAPLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-723-3929 LOVE IT OR IT'S ON US‡ *This product is not manufactured or distributed by Kenvue Inc., distributors of Imodium® A-D. 50844 REV0325Q37508 1. To open, tear at perforations and remove a section. 2. Use ✄ to cut through plastic for caplet. Signature Select 44-375 Signature Select 44-375

Overview

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Indications & Usage

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Dosage & Administration

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; but no more than 4 caplets in 24 hours 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; 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

Warnings & Precautions
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 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.
Purpose

Purpose Anti-diarrheal

Do Not Use

Do not use if you have bloody or black stool.

When Using

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use & Ask a Doctor

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.

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.

Storage & Handling

Other information each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20º-25ºC (68º-77ºF) see end flap for expiration date and lot number

Questions

Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday


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