{"active_ingredient":["Active ingredient (in each caplet) Loperamide HCl 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 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; 1/2 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; 1/2 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":["<table width=\"100%\"><col width=\"33%\"/><col width=\"67%\"/><tbody><tr><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children 9-11 years (60-95 lbs)</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children 6-8 years (48-59 lbs)</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children 2-5 years (34 to 47 lbs)</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>children under 2 years (up to 33 lbs)</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20250718","id":"dd0ee798-d323-4d39-a04c-d2e10df1cd2f","inactive_ingredient":["Inactive ingredients anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch"],"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 right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA075232"],"brand_name":["Leader Anti Diarrheal"],"generic_name":["LOPERAMIDE HCL"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health 110, LLC. dba Leader"],"package_ndc":["70000-0225-1","70000-0225-2"],"product_ndc":["70000-0225"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978010"],"spl_id":["dd0ee798-d323-4d39-a04c-d2e10df1cd2f"],"spl_set_id":["9079a59b-a158-4e77-a104-547959f7ba78"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"]},"package_label_principal_display_panel":["Principal Display Panel Anti-Diarrheal Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea COMPARE TO IMODIUM® A-D active ingredient 12 CAPLETS* *Capsule-Shaped Tablets Actual Size 100% Money Back Guarantee SEE NEW WARNINGS DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN 224-e9-anti-diarrheal.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-diarrheal"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"9079a59b-a158-4e77-a104-547959f7ba78","spl_product_data_elements":["Leader Anti Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE LOPERAMIDE ANHYDROUS LACTOSE CARNAUBA WAX D&C YELLOW NO. 10 FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED L2"],"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°-25°C (68°-77°F) • see end 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 HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use if you have bloody or black stool 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. 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."]}