{ "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": 22 } }, "results": [ { "spl_product_data_elements": [ "anti diarrheal and anti gas loperamide hydrochloride, simethicone LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE SILICON DIOXIDE ACESULFAME POTASSIUM CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL STEARIC ACID L0R1;2;125" ], "active_ingredient": [ "Active ingredients (in each caplet) Loperamide HCl 2 mg Simethicone 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. (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 printed blister unit is broken or torn" ], "inactive_ingredient": [ "Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Compare to the active ingredients in Imodium ® Multi-Symptom Relief Anti-Diarrheal & Anti-Gas LOPERAMIDE HYDROCHLORIDE & SIMETHICONE TABLETS, 2 mg/125 mg ANTI-DIARRHEAL/ANTI-GAS Multi-symptom relief caplet Relieves symptoms of diarrhea plus: Cramps & pressure Bloating Gas 24 CAPLETS* *Capsule-shaped tablets Actual Size anti diarrheal and anti gas image" ], "set_id": "065699b5-217e-432f-a253-cea2d3f62233", "id": "927820f7-afd0-4433-9202-86729b523a61", "effective_time": "20240720", "version": "4", "openfda": { "application_number": [ "ANDA209837" ], "brand_name": [ "anti diarrheal and anti gas" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE, SIMETHICONE" ], "manufacturer_name": [ "CVS Pharmacy" ], "product_ndc": [ "69842-644" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIMETHICONE", "LOPERAMIDE HYDROCHLORIDE" ], "rxcui": [ "978001" ], "spl_id": [ "927820f7-afd0-4433-9202-86729b523a61" ], "spl_set_id": [ "065699b5-217e-432f-a253-cea2d3f62233" ], "package_ndc": [ "69842-644-62", "69842-644-53" ], "is_original_packager": [ true ], "nui": [ "N0000010282" ], "pharm_class_pe": [ "Skin Barrier Activity [PE]" ], "unii": [ "92RU3N3Y1O", "77TI35393C" ] } } ] }