{"active_ingredient":["Active ingredient (in each softgel) Loperamide HCl 2 mg Purpose Anti-diarrheal"],"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 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 in children under 12 years of age"],"dosage_and_administration":["Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours"],"effective_time":"20221101","id":"ec6b87f1-e600-21c2-e053-2a95a90ab76d","inactive_ingredient":["Inactive ingredients butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water."],"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":["NDA021855"],"brand_name":["WELMATE Anti Diarrheal Loperamide HCl Softgels"],"generic_name":["LOPERAMIDE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["YYBA CORP"],"package_ndc":["73581-102-24"],"product_ndc":["73581-102"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978006"],"spl_id":["ec6b87f1-e600-21c2-e053-2a95a90ab76d"],"spl_set_id":["ae2e15e9-1707-296d-e053-2995a90a1b95"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"],"upc":["0373581102242"]},"package_label_principal_display_panel":["Package Labeling: Label2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-diarrheal"],"questions":["Questions? call toll-free 1-800-935-6737"],"set_id":"ae2e15e9-1707-296d-e053-2995a90a1b95","spl_product_data_elements":["WELMATE Anti Diarrheal Loperamide HCl Softgels LOPERAMIDE HYDROCHLORIDE BUTYLATED HYDROXYANISOLE FD&C BLUE NO. 1 GELATIN GLYCERIN GLYCERYL CAPRYLATE POLYOXYL 40 HYDROGENATED CASTOR OIL WATER LOPERAMIDE HYDROCHLORIDE LOPERAMIDE LP2"],"spl_unclassified_section":["Drug Facts","Other information do not use if blister unit is torn or open store at 20°- 25°C (68° - 77°F)"],"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":"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. Do not use: if you have bloody or black stool in children under 12 years of age 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."]}