{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "IMODIUM Multi-Symptom Relief loperamide hydrochloride and dimethicone CROSCARMELLOSE SODIUM ACESULFAME POTASSIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE IMO;2;125" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredients (in each caplet) Purposes Loperamide HCl 2 mg Anti-diarrheal Simethicone 125 mg Anti-gas" ], "active_ingredient_table": [ "
Active ingredients (in each caplet)Purposes
Loperamide HCl 2 mgAnti-diarrheal
Simethicone 125 mgAnti-gas
" ], "purpose": [ "Active ingredients (in each caplet) Purposes Loperamide HCl 2 mg Anti-diarrheal Simethicone 125 mg Anti-gas" ], "purpose_table": [ "
Active ingredients (in each caplet)Purposes
Loperamide HCl 2 mgAnti-diarrheal
Simethicone 125 mgAnti-gas
" ], "indications_and_usage": [ "Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas" ], "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)" ], "do_not_use": [ "Do not use if you have bloody or black stool if you have difficulty swallowing" ], "ask_doctor": [ "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_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs." ], "when_using": [ "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "stop_use": [ "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." ], "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)" ], "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 9-11 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" ], "dosage_and_administration_table": [ "
adults and children 12 years and over2 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
" ], "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)" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC 50580-338-12 Imodium ® Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas Multi-Symptom Relief Caplet Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 Caplets* *capsule-shaped tablets Actual Size imodium-1" ], "set_id": "ecb91e47-2b0c-47c8-9256-4623d8bc825e", "id": "490ec903-14a6-e576-e063-6294a90a6d13", "effective_time": "20260123", "version": "23", "openfda": { "application_number": [ "NDA021140" ], "brand_name": [ "IMODIUM Multi-Symptom Relief" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-338" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE", "DIMETHICONE" ], "rxcui": [ "978001", "1426827" ], "spl_id": [ "490ec903-14a6-e576-e063-6294a90a6d13" ], "spl_set_id": [ "ecb91e47-2b0c-47c8-9256-4623d8bc825e" ], "package_ndc": [ "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" ], "is_original_packager": [ true ], "upc": [ "0300450212122" ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "77TI35393C", "92RU3N3Y1O" ] } } ] }