{"active_ingredient":["Active ingredients (in each caplet) Loperamide HCl, 2 mg Simethicone, 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 ag 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 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use Other information each caplet contains: calcium 148.40 mg, sodium 1.40 mg store between 20-25°C (68-77°F). Protect from light. for blister: do not use if blister unit is torn or broken"],"dosage_and_administration_table":["
adults and children 12 years and over2 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 2-5 years (34 to 47 lbs)ask a doctor
children under 2 years (up to 33 lbs)do not use
"],"effective_time":"20251201","id":"44e3c6ff-dda8-ee9e-e063-6394a90a03bb","inactive_ingredient":["Inactive Ingredients acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid. Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST Manufactured by: Granules India Limited Hyderabad-500 081, INDIA MADE IN INDIA"],"indications_and_usage":["Uses 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":["ANDA215981"],"brand_name":["Loperamide Hydrochloride and Simethicone"],"generic_name":["LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Granules India Ltd"],"nui":["N0000010282"],"package_ndc":["62207-739-69"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["62207-739"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["44e3c6ff-dda8-ee9e-e063-6394a90a03bb"],"spl_set_id":["e0c1693e-0e55-4368-a8a5-2f0882fbf952"],"substance_name":["LOPERAMIDE HYDROCHLORIDE","DIMETHICONE"],"unii":["77TI35393C","92RU3N3Y1O"],"upc":["0362207739696"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg ANTI-DIARRHEAL / ANTI-GAS Multi-Symptom Relief Caplet Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 Caplets * *capsule-shaped tablets foil carton"],"purpose":["Purposes Anti-diarrheal Anti-gas"],"recent_major_changes":[""],"set_id":"e0c1693e-0e55-4368-a8a5-2f0882fbf952","spl_product_data_elements":["Loperamide Hydrochloride and Simethicone Loperamide Hydrochloride and Simethicone MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM ACESULFAME POTASSIUM STEARIC ACID ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE off white Capsule shaped tablet I;9"],"spl_unclassified_section":["SPL UNCLASSIFIED SECTION Drug Facts"],"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 caplet If pregnant or breast-feeding , ask a health professional before use."],"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"],"when_using":["When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery."]}