{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Loperamide HCl and Simethicone Loperamide HCl and Simethicone LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE CALCIUM SILICATE SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO white to off-white NA" ], "active_ingredient": [ "Active ingredients (in each caplet) Loperamide HCl USP, 2 mg Simethicone USP, 125 mg" ], "purpose": [ "Purposes Anti-diarrheal Anti-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 (1800-222-1222)." ], "do_not_use": [ "Do not use • if you have bloody or black stool • if you have difficulty swallowing" ], "when_using": [ "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery ." ], "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 (1800-222-1222)." ], "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; 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 (upto 33 lbs) do not use Other information • calcium: contains 142 mg/caplet • store between 20-25° C (68-77° F). Protect from light. • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN." ], "dosage_and_administration_table": [ "
adults and children 12 years and over2 caplets after the first loosestool; 1 caplet after eachsubsequent loose stool;but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)1 caplet after the first loosestool; 1/2 caplet after eachsubsequent loose stool;but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)1 caplet after the first loosestool; 1/2 caplet after eachsubsequent 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 (upto 33 lbs)do not use
" ], "inactive_ingredient": [ "Inactive ingredients calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid" ], "questions": [ "Questions? call 1-800-406-7984" ], "spl_unclassified_section": [ "Manufactured by: Sun Pharmaceutical Industries Limited, MOHALI, INDIA Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-06 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 6 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton", "PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-12 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton", "PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-18 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 18 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton", "PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-24 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 24 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton" ], "set_id": "06f99f59-e702-49f1-bb1d-e7cf58c54c30", "id": "86ddd92a-920c-40b8-b0bd-29bfb3b38bfc", "effective_time": "20220830", "version": "3", "openfda": { "application_number": [ "ANDA077500" ], "brand_name": [ "Loperamide HCl and Simethicone" ], "generic_name": [ "LOPERAMIDE HCL AND SIMETHICONE" ], "manufacturer_name": [ "Ohm Laboratories Inc." ], "product_ndc": [ "51660-069" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIMETHICONE", "LOPERAMIDE HYDROCHLORIDE" ], "rxcui": [ "978001" ], "spl_id": [ "86ddd92a-920c-40b8-b0bd-29bfb3b38bfc" ], "spl_set_id": [ "06f99f59-e702-49f1-bb1d-e7cf58c54c30" ], "package_ndc": [ "51660-069-06", "51660-069-12", "51660-069-18", "51660-069-24" ], "is_original_packager": [ true ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "92RU3N3Y1O", "77TI35393C" ] } } ] }