{"active_ingredient":["Drug Facts Active ingredient (in each tablet) Loperamide hydrochloride USP 2 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"],"dosage_and_administration":["Directions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9 to 11 years (60 to 95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6 to 8 years (48 to 59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 cellpadding=\"0pt\" cellspacing=\"0pt\" width=\"100%\"><col width=\"29%\"/><col width=\"69%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>adults and children 12 years and over </paragraph></td><td styleCode=\"Rrule Botrule Toprule \" valign=\"middle\"><paragraph>2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 9 to 11 years (60 to 95 lbs) </paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 6 to 8 years (48 to 59 lbs) </paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours </paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 2 to 5 years (34 to 47 lbs) </paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>ask a doctor </paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"middle\"><paragraph>children under 2 years (up to 33 lbs) </paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"middle\"><paragraph>do not use </paragraph></td></tr></tbody></table>"],"effective_time":"20260528","id":"4e0998b5-f4d3-4f1d-9244-07f3c78308c6","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate"],"indications_and_usage":["Use controls symptoms of diarrhea, including Travelers' Diarrhea"],"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."],"openfda":{"application_number":["ANDA206548"],"brand_name":["Loperamide Hydrochloride"],"generic_name":["LOPERAMIDE HYDROCHLORIDE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["58602-701"],"package_ndc":["68788-8393-2"],"product_ndc":["68788-8393"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978010"],"spl_id":["4e0998b5-f4d3-4f1d-9244-07f3c78308c6"],"spl_set_id":["5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets) AUROHEALTH Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8393 *Compare to the active ingredient of Imodium ® A-D Loperamide Hydrochloride Tablets USP 2 mg Anti-Diarrheal Controls the symptoms of diarrhea 24 Tablets Loperamide HCL Tablets USP 2mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-diarrheal"],"questions":["Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code .: TS/DRUGS/22/2009 Relabeled By: Preferred Pharmaceuticals Inc."],"set_id":"5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf","spl_product_data_elements":["Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE SILICON DIOXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO Light Green Biconvex L;28"],"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."],"storage_and_handling":["Other information • store at 20° to 25°C (68° to 77°F). • do not use if carton or blister unit is open or torn • Meets USP dissolution test 2 • See side panel for lot number and expiration date"],"version":"5","warnings":["Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride 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."]}