{ "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": 2 } }, "results": [ { "spl_product_data_elements": [ "Anti-Diarrheal/Anti-Gas Caplets Loperamide Hydrochloride 2mg, Simethicone 125mg ACESULFAME POTASSIUM SILICON DIOXIDE CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE off-white L;II" ], "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": [ "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 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 have difficulty swallowing the caplet you get abdominal swelling or bulging. These may be signs of a serious condition." ], "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 (1-800-222-1222) right away." ], "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 155 mg, sodium 3 mg store at 20-25°C (68-77°F) protect from light" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor" ], "questions": [ "Questions? call toll-free 1-866-933-6337" ], "package_label_principal_display_panel": [ "Principal Display Panel label" ], "set_id": "46f5c653-eec2-4729-8aaa-79f2e188eac3", "id": "3cb7329c-a47c-5d2f-e063-6394a90a053d", "effective_time": "20250724", "version": "1", "openfda": { "application_number": [ "ANDA213484" ], "brand_name": [ "Anti-Diarrheal/Anti-Gas Caplets" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG" ], "manufacturer_name": [ "YYBA CORP" ], "product_ndc": [ "73581-178" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE", "DIMETHICONE" ], "rxcui": [ "978001" ], "spl_id": [ "3cb7329c-a47c-5d2f-e063-6394a90a053d" ], "spl_set_id": [ "46f5c653-eec2-4729-8aaa-79f2e188eac3" ], "package_ndc": [ "73581-178-24" ], "is_original_packager": [ true ], "upc": [ "0373581000722" ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "77TI35393C", "92RU3N3Y1O" ] } } ] }