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FDA LABEL GENERIC: Loperamide MFR: Kenvue Brands LLC

Imodium Multi-symptom Relief (loperamide Hcl 2 Mg / Simethicone 125 Mg) Oral Tablet

Table of Contents

Drug Facts

Active ingredients (in each caplet) Purposes
Loperamide HCl 2 mg Anti-diarrheal
Simethicone 125 mg Anti-gas

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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 if you have difficulty swallowing

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. you have difficulty swallowing the caplet

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 take only on an empty stomach (1 hour before or 2 hours after a meal) take with a full (8 oz.) glass of water find right dose on chart below. 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;

½ 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;

½ 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

Other information

each caplet contains: calcium 165 mg, sodium 3 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken

Inactive ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

NDC 50580-338-52

Imodium ®

Multi-Symptom Relief

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

Relieves symptoms
of diarrhea plus

Cramps & Pressure Bloating Gas

24 Caplets*

*capsule-shaped tablets

Actual Size