{"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 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 liquid 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 (34-47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use"],"dosage_and_administration_table":["<table width=\"600px\" cellspacing=\"0\"><col/><col/><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"><paragraph><content styleCode=\"bold\">adults and children 12 years and over</content></paragraph></td><td styleCode=\"Botrule Lrule Rrule Toprule\">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><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">children 9-11 years (60-95 lbs)</content></td><td styleCode=\"Botrule Lrule Rrule Toprule\">1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">children 6-8 years (48-59 lbs)</content></td><td styleCode=\"Botrule Lrule Rrule Toprule\">1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">children 2-5 years (34-47 lbs)</content></td><td styleCode=\"Botrule Lrule Rrule Toprule\">ask a doctor</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\"><content styleCode=\"bold\">children under 2 years (up to 33 lbs)</content></td><td styleCode=\"Botrule Lrule Rrule Toprule\">do not use</td></tr></tbody></table>"],"effective_time":"20240811","id":"1f6363e2-256d-68c3-e063-6394a90ac6c1","inactive_ingredient":["Inactive ingredients corn starch, D&C yellow#10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel."],"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":["ANDA076497"],"brand_name":["Anti-Diarrheal"],"generic_name":["LOPERAMIDE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"package_ndc":["80513-401-24"],"product_ndc":["80513-401"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978010"],"spl_id":["1f6363e2-256d-68c3-e063-6394a90ac6c1"],"spl_set_id":["287bd6d9-aa29-4f56-9c7f-5cbacbf62537"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"],"upc":["0380513001030"]},"other_safety_information":["Other information do not use if seal around caplet is broken or damaged store between 20° and 25°C (68° and 77°F) KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TEMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT."],"package_label_principal_display_panel":["Principal Display Panel NDC 80513-401-24 Compare to the active ingredient in Imodium ® A-D* Anti-Diarrheal Loperamide Hydrocholoride Caplets, 2 mg Controls Symptoms of Diarrhea Easy To Swallow 24 CAPLETS *This product is not manufactured or distributed by the owner of the registered trademark Imodium ® A-D. label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-diarrheal"],"questions":["Questions? call toll-free 1-800-630-8895"],"set_id":"287bd6d9-aa29-4f56-9c7f-5cbacbf62537","spl_product_data_elements":["Anti-Diarrheal Loperamide Hydrochloride STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 44;375"],"spl_unclassified_section":["Distributed by: ADVANCED RX LLC, 1942 NE 163rd St, North Miami Beach, FL 33162 U.S.A."],"stop_use":["Stop use and ask a doctor if symptoms get worse diarrhea lasts more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition."],"version":"1","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 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 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 (1-800-222-1222) right away."],"when_using":["When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery."]}