{"active_ingredient":["Active ingredients (in each caplet) Loperamide HCl USP, 2 mg Simethicone USP, 125 mg"],"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 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 to 47 lbs) ask a doctor children under 2 years (upto 33 lbs) do not use Other information • calcium: contains 142 mg/caplet • store between 20-25° C (68-77° F). Protect from light. • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN."],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph>adults and children 12 years and over</paragraph></td><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph>2 caplets after the first loose</paragraph><paragraph>stool; 1 caplet after each</paragraph><paragraph>subsequent loose stool;</paragraph><paragraph>but no more than 4 caplets in 24 hours</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>children 9-11 years (60-95 lbs)</paragraph></td><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>1 caplet after the first loose</paragraph><paragraph>stool; 1/2 caplet after each</paragraph><paragraph>subsequent loose stool;</paragraph><paragraph>but no more than 3 caplets in 24 hours</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>children 6-8 years (48-59 lbs)</paragraph></td><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>1 caplet after the first loose</paragraph><paragraph>stool; 1/2 caplet after each</paragraph><paragraph>subsequent loose stool;</paragraph><paragraph>but no more than 2 caplets in 24 hours</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>children 2-5 years (34 to 47 lbs)</paragraph></td><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>ask a doctor</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule \"><paragraph>children under 2 years (upto 33 lbs)</paragraph></td><td valign=\"top\" styleCode=\"Rrule Botrule Lrule \"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"effective_time":"20220830","id":"86ddd92a-920c-40b8-b0bd-29bfb3b38bfc","inactive_ingredient":["Inactive ingredients calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid"],"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 (1800-222-1222)."],"openfda":{"application_number":["ANDA077500"],"brand_name":["Loperamide HCl and Simethicone"],"generic_name":["LOPERAMIDE HCL AND SIMETHICONE"],"is_original_packager":[true],"manufacturer_name":["Ohm Laboratories Inc."],"nui":["N0000010282"],"package_ndc":["51660-069-06","51660-069-12","51660-069-18","51660-069-24"],"pharm_class_pe":["Skin Barrier Activity [PE]"],"product_ndc":["51660-069"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["978001"],"spl_id":["86ddd92a-920c-40b8-b0bd-29bfb3b38bfc"],"spl_set_id":["06f99f59-e702-49f1-bb1d-e7cf58c54c30"],"substance_name":["LOPERAMIDE HYDROCHLORIDE","DIMETHICONE"],"unii":["77TI35393C","92RU3N3Y1O"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-06 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 6 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton","PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-12 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton","PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-18 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 18 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton","PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton † Compare To the active ingredients of Imodium ® Multi-Symptom Relief NDC 51660-069-24 ohm ® Loperamide HCl and Simethicone Tablets, 2 mg/125 mg Anti-Diarrheal/Anti-Gas Multi-Symptom Relief Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 24 CAPLETS* (*capsule-shaped tablets) PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton"],"purpose":["Purposes Anti-diarrheal Anti-gas"],"questions":["Questions? call 1-800-406-7984"],"set_id":"06f99f59-e702-49f1-bb1d-e7cf58c54c30","spl_product_data_elements":["Loperamide HCl and Simethicone Loperamide HCl and Simethicone LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE CALCIUM SILICATE SILICON DIOXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO white to off-white NA"],"spl_unclassified_section":["Manufactured by: Sun Pharmaceutical Industries Limited, MOHALI, INDIA Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901"],"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 • 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 caplet 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 (1800-222-1222)."],"when_using":["When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery ."]}