{"active_ingredient":["ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCl USP, 2 mg"],"ask_doctor":["Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking antibiotics"],"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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"47%\"/><col width=\"53%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Rrule Botrule 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=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 9-11 years (60-95 lbs)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1 caplet after the first loose stool; &#xBD; caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 6-8 years (48-59 lbs)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>1 caplet after the first loose stool; &#xBD; caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>children under 6 years (up to 47 lbs)</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20220502","id":"4b48b484-e780-4b66-a6ca-35c5d61bcf41","inactive_ingredient":["INACTIVE INGREDIENTS anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch"],"indications_and_usage":["USE(S) 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":["ANDA074091"],"brand_name":["Loperamide Hydrochloride"],"generic_name":["LOPERAMIDE HYDROCHLORIDE"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["51660-123"],"package_ndc":["63187-462-12"],"product_ndc":["63187-462"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978010"],"spl_id":["4b48b484-e780-4b66-a6ca-35c5d61bcf41"],"spl_set_id":["82e65393-25b7-4114-9c71-5840ee8bad84"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"],"upc":["0363187462123"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 63187-462-12 Loperamide HCl Tablets, USP 2 mg Anti-Diarrheal 12 CAPLETS † Each caplet( † capsule-shaped tablet) contains Loperamide HCl, USP 2 mg Controls The Symptoms of Diarrhea * Compare to the active ingredient of Imodium ® A-D * This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium ® A-D . Imodium ® is a registered trademark of Johnson & Johnson. 63187-462-12"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSE Anti-diarrheal"],"questions":["QUESTIONS? call 1800-406-7984 Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320"],"set_id":"82e65393-25b7-4114-9c71-5840ee8bad84","spl_product_data_elements":["Loperamide Hydrochloride Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CROSCARMELLOSE SODIUM CROSPOVIDONE (120 .MU.M) D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN GLYCERYL TRISTEARATE ANHYDROUS LACTOSE 123"],"stop_use":["Stop use and ask a doctor if • diarrhea lasts for more than 2 days • symptoms get worse • you get abdominal swelling or bulging. These may be signs of a serious condition."],"storage_and_handling":["OTHER INFORMATION • store between 20° – 25° C (68° – 77° F) • see side panel for lot number and expiration date • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN."],"version":"6","warnings":["WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI 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 Ask a doctor or pharmacist before use if you are taking antibiotics When using this product • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if • diarrhea lasts for more than 2 days • symptoms get worse • 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."]}