{"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":"20251023","id":"41d6dba5-e412-c8d2-e063-6294a90ae8fa","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":["IMO-GEN LABS LLC"],"nui":["N0000010282"],"package_ndc":["84441-713-10"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["84441-713"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["41d6dba5-e412-c8d2-e063-6294a90ae8fa"],"spl_set_id":["41d6dba5-e411-c8d2-e063-6294a90ae8fa"],"substance_name":["DIMETHICONE","LOPERAMIDE HYDROCHLORIDE"],"unii":["92RU3N3Y1O","77TI35393C"],"upc":["0860010278123"]},"other_safety_information":["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"],"package_label_principal_display_panel":["Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg IBS-10 label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["PURPOSES Anti-diarrheal Anti-gas"],"set_id":"41d6dba5-e411-c8d2-e063-6294a90ae8fa","spl_product_data_elements":["Loperamide Hydrochloride and Simethicone Loperamide Hydrochloride and Simethicone DIMETHICONE DIMETHICONE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE ACESULFAME POTASSIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS STEARIC ACID CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM H;L21"],"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 If pregnant or breast-feeding , ask a health professional before use."],"version":"1","warnings":["WARNINGS Allergry alert: Do not user 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. DO NOT USE • if you have bloody or black stool • if you have difficulty swallowing 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. • you have difficulty swallowing the tablet If pregnant or breast-feeding , ask a health professional before use. 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)","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."]}