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Loperamide Hydrochloride and Simethicone

OTC Oral RxCUI 978001
Contents

Overview

Active ingredient
Loperamide Hydrochloride, Dimethicone
Physiologic effect
Skin Barrier Activity
Route
Oral
Label date
2026-01-05

Indications and usage

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

Purpose

s Anti-diarrheal Anti-gas

Dosage and administration

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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbsto 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

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)

Do not use

if you have bloody or black stool if you have difficulty swallowing

Ask a doctor before use if

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

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

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

Stop use and ask a doctor if

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

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Active ingredient (label)

s (in each caplet) Loperamide HCl, USP 2 mg Simethicone, USP 125 mg

Inactive ingredients

s acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Storage and handling

Other information each caplet contains: calcium 155 mg, sodium 3 mg store between 20° to 25°C (68° to 77°F). Protect from light.

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)