Anti Diarrheal LOPERAMIDE HCL CHAIN DRUG MARKETING ASSOCIATION INC FDA Approved Use controls symptoms of diarrhea, including Travelers’ Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA076497

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
2362 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
UPC
0635515996403
UNII
77TI35393C
Packaging

Principal display panel QC ® Quality Choice NDC 63868-559-12 *Compare to the active ingredient in IMODIUM® A-D Anti-Diarrheal Loperamide HCl Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea actual size 12 Caplets TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark IMODIUM® A-D. Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 1. To open, tear 2. Use ✄ to cut at perforations and through plastic remove a section. for caplet. 50844 REV0619B37502 Quality Choice 44-375 Quality Choice 44-375

Package Descriptions
  • Principal display panel QC ® Quality Choice NDC 63868-559-12 *Compare to the active ingredient in IMODIUM® A-D Anti-Diarrheal Loperamide HCl Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea actual size 12 Caplets TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark IMODIUM® A-D. Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 1. To open, tear 2. Use ✄ to cut at perforations and through plastic remove a section. for caplet. 50844 REV0619B37502 Quality Choice 44-375 Quality Choice 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 (34-47 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 a 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 TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store between 20°-25°C (68°-77°F) 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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