IM

OTC products · Product label record

IMODIUM Multi-Symptom Relief drug information

LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE
Kenvue Brands LLC · ORAL

Product NDC: 50580-338

Join the community
CommunityExperiencesReviewsDrug database
Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameLOPERAMIDE HYDROCHLORIDE AND DIMETHICONE
Labeler / manufacturerKenvue Brands LLC
RouteORAL
Drug classDrug class not supplied in source label
Product NDC50580-338
Label effective date2026-08-25

Official product label reference

IMODIUM Multi-Symptom Relief — Kenvue Brands LLC

This page contains 16 source sections for LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE, oral route. Label set ecb91e47-2b0c-47c8-9256-4623d8bc825e, version 24.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Active ingredients (in each caplet) Purposes Loperamide HCl 2 mg Anti-diarrheal Simethicone 125 mg Anti-gas Table text from source: | Active ingredients (in each caplet) | Purposes | Loperamide HCl 2 mg | Anti-diarrheal | Simethicone 125 mg | Anti-gas
Dosage and administration — label text
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 Table text from source: | 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
Warnings
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)
Unclassified section
Drug Facts
Active ingredient
Active ingredients (in each caplet) Purposes Loperamide HCl 2 mg Anti-diarrheal Simethicone 125 mg Anti-gas Table text from source: | Active ingredients (in each caplet) | Purposes | Loperamide HCl 2 mg | Anti-diarrheal | Simethicone 125 mg | Anti-gas
Do not use
Do not use if you have bloody or black stool if you have difficulty swallowing
Ask a doctor before use
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
Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
While using this medicine
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
When to stop use and seek help
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
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
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 and handling
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 ingredient
Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid
Questions
Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Official sources and product identifiers

Substances listed: LOPERAMIDE HYDROCHLORIDE, DIMETHICONE

RxNorm identifiers: 978001, 1426827

Package NDC codes

50580-338-12, 50580-338-18, 50580-338-42, 50580-338-30, 50580-338-60, 50580-338-61, 50580-338-64, 50580-338-06, 50580-338-07, 50580-338-52, 50580-338-51, 50580-338-50

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.