{"active_ingredient":["ACTIVE INGREDIENT(S) (in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 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 • if you have difficulty swallowing"],"dosage_and_administration":["DIRECTIONS • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. 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 9-11 years (60-95 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 6-8 years (48-59 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 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use"],"dosage_and_administration_table":["
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 9-11 years (60-95 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 6-8 years (48-59 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 2-5 years (34 to 47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use
"],"effective_time":"20250405","id":"32034b0b-931b-ef49-e063-6394a90a2bc3","inactive_ingredient":["INACTIVE INGREDIENTS acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor"],"indications_and_usage":["USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas"],"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":["ANDA211438"],"brand_name":["Loperamide Hydrochloride and Simethicone"],"generic_name":["LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["FSA store INC"],"nui":["N0000010282"],"package_ndc":["81522-325-24"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["81522-325"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["32034b0b-931b-ef49-e063-6394a90a2bc3"],"spl_set_id":["0199a50f-f367-40e7-8af0-745a959d3fde"],"substance_name":["LOPERAMIDE HYDROCHLORIDE","DIMETHICONE"],"unii":["77TI35393C","92RU3N3Y1O"],"upc":["0369230325247"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil loperamidesimethiconecarton loperamidesimethiconefoil"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["PURPOSES Anti-diarrheal Anti-gas"],"set_id":"0199a50f-f367-40e7-8af0-745a959d3fde","spl_product_data_elements":["Loperamide Hydrochloride and Simethicone Loperamide Hydrochloride and Simethicone ACESULFAME POTASSIUM CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE H;L21"],"spl_unclassified_section":["OTHER INFORMATION • each tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg • store between 20 to 25°C (68 to 77°F). Protect from light. • do not use if carton is open or if blister unit is open or torn","QUESTIONS OR COMMENTS call 1-888-588-1418 Manufactured for FSA Store Inc. 473 Blair Rd Suite 100 PMB 24308 Dallas, TX 75231 Customer Help Line: 1-888-588-1418"],"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. • you have difficulty swallowing the tablet"],"version":"1","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."]}