{"active_ingredient":["Drug Facts 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 to 11 years (60 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 to 8 years (48 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 to 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 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 to 11 years (60 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 to 8 years (48 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 to 5 years (34 to 47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
"],"effective_time":"20250107","id":"f2788da1-1ef1-4db9-8271-e786cc2ddd9e","inactive_ingredient":["Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate anhydrous, flavor, microcrystalline cellulose, stearic acid."],"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":["ANDA211059"],"brand_name":["Loperamide Hydrochloride and Simethicone"],"generic_name":["LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"nui":["N0000010282"],"package_ndc":["58602-815-74","58602-815-75","58602-815-80","58602-815-76"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["58602-815"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["f2788da1-1ef1-4db9-8271-e786cc2ddd9e"],"spl_set_id":["9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f"],"substance_name":["LOPERAMIDE HYDROCHLORIDE","DIMETHICONE"],"unii":["77TI35393C","92RU3N3Y1O"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label AUROHEALTH NDC 58602-815-76 ** Compare to the active ingridients of Imodium® Multi-Sympton Relief Loperamide HCl and Simethicone Tablets 2 mg/125 mg Loperamide HCl 2 mg - Antidiarrheal Simethicone 125 mg - Anti-gas Multi-Sympton Relief C aplet Relieves symptoms of diarrhea plus • Cramps & Pressure • Bloating • Gas 24 Caplets* *capsule-shaped tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label"],"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 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016"],"set_id":"9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f","spl_product_data_elements":["Loperamide Hydrochloride and Simethicone Loperamide Hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE ACESULFAME POTASSIUM CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 STEARIC ACID off-white T;79"],"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 165 mg, sodium 4 mg store between 20° to 25°C (68° to 77°F). Protect from light. do not use if carton is opened or if individual blister units are torn or opened"],"version":"5","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"],"when_using":["When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery."]}