{"active_ingredient":["Active ingredients (in each caplet) Loperamide HCl, USP 2 mg Simethicone, USP 125 mg"],"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."],"do_not_use":["Do not use if you have bloody or black stool if you have difficulty swallowing"],"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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbsto 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use"],"dosage_and_administration_table":["<table width=\"50%\"><col align=\"left\" valign=\"top\" width=\"40%\"/><col align=\"left\" valign=\"top\" width=\"60%\"/><tbody><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Rrule Toprule\">adults and children 12 years and over</td><td align=\"left\" styleCode=\"Toprule\">2 caplets after the first loose stool;    1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours </td></tr><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Rrule\">children 9 years to 11 years    (60 lbs to 95 lbs) </td><td align=\"left\">1 caplet after the first loose stool;    &#xBD; caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours </td></tr><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Rrule\">children 6 years to 8 years    (48 lbs to 59 lbs) </td><td align=\"left\">1 caplet after the first loose stool;    &#xBD; caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours </td></tr><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Rrule\">children 2 years to 5 years    (34 lbsto 47 lbs) </td><td align=\"left\">ask a doctor</td></tr><tr><td align=\"left\" styleCode=\"Rrule Toprule\">children under 2 years    (up to 33 lbs) </td><td align=\"left\" styleCode=\"Toprule\">do not use</td></tr></tbody></table>"],"effective_time":"20260105","id":"47a779be-990b-5c3b-e063-6394a90ac456","inactive_ingredient":["Inactive ingredients acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor"],"indications_and_usage":["Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas"],"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)"],"openfda":{"application_number":["ANDA213484"],"brand_name":["Loperamide hydrochloride and Simethicone"],"generic_name":["LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Bionpharma Inc."],"nui":["N0000010282"],"package_ndc":["69452-531-12"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["69452-531"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["47a779be-990b-5c3b-e063-6394a90ac456"],"spl_set_id":["47a779c7-c709-6208-e063-6394a90a6dfa"],"substance_name":["LOPERAMIDE HYDROCHLORIDE","DIMETHICONE"],"unii":["77TI35393C","92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL ⱡCompare to the active ingredients in Imodium ® Multi-Symptom Relief anti-diarrheal/anti-gas Loperamide HCl and simethicone tablets, 2 mg/125 mg multi-symptom relief c aplet Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 24 Caplets* *Capsule-shaped Tablets image01"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Anti-diarrheal Anti-gas"],"questions":["Questions or comments? call toll-free 1-888-235-2466 ⱡThis product is not manufactured or distributed by the owners of Imodium ® Multi-Symptom Relief THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Manufactured for: BIONPHARMA Princeton, NJ 08540 MADE IN INDIA L0001183 R1025 Code: TN/Drugs/TN00002222/2006 949129361"],"set_id":"47a779c7-c709-6208-e063-6394a90a6dfa","spl_product_data_elements":["Loperamide hydrochloride and Simethicone loperamide hydrochloride and simethicone ACESULFAME POTASSIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS SILICON DIOXIDE CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE STEARIC ACID VANILLA LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE off-white LII"],"spl_unclassified_section":["Drug Facts"],"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"],"storage_and_handling":["Other information each caplet contains: calcium 155 mg, sodium 3 mg store between 20° to 25°C (68° to 77°F). Protect from light."],"version":"1","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)"],"when_using":["When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery."]}