Leader Anti Diarrheal LOPERAMIDE HCL CARDINAL HEALTH 110, LLC. DBA LEADER FDA Approved Use controls symptoms of diarrhea, including Travelers’ Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA075232

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Loperamide HCl 2 mg
Inactive Ingredients
Inactive ingredients anhydrous lactose carnauba wax D&C yellow no. 10 aluminum lake FD&C blue no. 1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol pregelatinized starch
Strengths
2 mg
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: oval Color: green Imprint: L2

Identifiers & Packaging

Container Type BOX
UNII
77TI35393C
Packaging

Principal Display Panel Anti-Diarrheal Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea COMPARE TO IMODIUM® A-D active ingredient 12 CAPLETS* *Capsule-Shaped Tablets Actual Size 100% Money Back Guarantee SEE NEW WARNINGS DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN 224-e9-anti-diarrheal.jpg

Package Descriptions
  • Principal Display Panel Anti-Diarrheal Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea COMPARE TO IMODIUM® A-D active ingredient 12 CAPLETS* *Capsule-Shaped Tablets Actual Size 100% Money Back Guarantee SEE NEW WARNINGS DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN 224-e9-anti-diarrheal.jpg

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 (1-800-222-1222).
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 (1-800-222-1222).

Storage & Handling

Other information • store at 20°-25°C (68°-77°F) • see end panel for lot number and expiration date

Questions

Questions or comments? 1-800-719-9260


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