{"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":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"86%\"><colgroup><col width=\"47.06%\"/><col width=\"52.94%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"top\">adults and children 12 years and over </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"top\">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 styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"top\">children 9 to 11 years (60 to 95 lbs) </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"top\">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 styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"top\">children 6 to 8 years (48 to 59 lbs) </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"top\">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 styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"top\">children 2 to 5 years (34 to 47 lbs) </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"top\">ask a doctor </td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"top\">children under 2 years (up to 33 lbs) </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"top\">do not use </td></tr></tbody></table>"],"effective_time":"20250107","id":"d9e5ddb4-1b09-440f-82af-b3dd59ef3ec0","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":["Better Living Brands, LLC"],"nui":["N0000010282"],"package_ndc":["21130-222-76","21130-222-24"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["21130-222"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["d9e5ddb4-1b09-440f-82af-b3dd59ef3ec0"],"spl_set_id":["fad9a144-6d1e-be06-e053-6394a90a870c"],"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 Compare to Imodium ® Multi-Symptom Relief active ingredients ** NDC 21130-222-24 MULTI-SYMPTOM RELIEF CAPLET Anti - Diarrheal/ Anti - Gas LOPERAMIDE HCl AND SIMETHICONE TABLETS 2 mg/125 mg Anti-Diarrheal/ Anti-Gas Relieves symptoms of diarrhea plus • Cramps & Pressure • Bloating • Gas Actual Size 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: BETTER LIVING BRANDS LLC P.O.BOX 99 PLEASANTON, CA 94566-0009 ‡1-888-723-3929 Made in India Code: AP/DRUGS/04/2016"],"set_id":"fad9a144-6d1e-be06-e053-6394a90a870c","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":"3","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."]}