{"active_ingredient":["Active ingredient (in each 7.5 mL) Loperamide HCl, USP 1 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"],"dosage_and_administration":["Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise use age. shake well before using use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9 years to 11 years (60 lbs to 95 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6 years to 8 years (48 lbs to 59 lbs) 15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours children 2 years to 5 years (34 lbs to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule First Lrule Rrule Toprule\"><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">adults and children 12 years and over</td><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours</td></tr><tr styleCode=\"Botrule Lrule Rrule Toprule\"><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">children 9 years to 11 years (60 lbs to 95 lbs)</td><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours</td></tr><tr styleCode=\"Botrule Lrule Rrule Toprule\"><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">children 6 years to 8 years (48 lbs to 59 lbs)</td><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours</td></tr><tr styleCode=\"Botrule Lrule Rrule Toprule\"><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">children 2 years to 5 years (34 lbs to 47 lbs)</td><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">ask a doctor</td></tr><tr><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">children under 2 years (up to 33 lbs)</td><td align=\"left\" styleCode=\"Botrule First Lrule Rrule Toprule\">do not use</td></tr></tbody></table>"],"effective_time":"20260320","id":"4db35024-40dc-22ee-e063-6394a90a0946","inactive_ingredient":["Inactive ingredients anhydrous citric acid, D&C yellow no. 10, FD&C blue no. 1, flavadew coolmint, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, plain caramel powder, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum"],"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 right away. (1-800-222-1222)"],"openfda":{"application_number":["ANDA220100"],"brand_name":["Loperamide Hydrochloride"],"generic_name":["LOPERAMIDE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["DOLGENCORP INC"],"package_ndc":["55910-155-55"],"product_ndc":["55910-155"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1250685"],"spl_id":["4db35024-40dc-22ee-e063-6394a90a0946"],"spl_set_id":["4db35031-f765-39a6-e063-6394a90a40c9"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL-4 fl oz DG TM health *Compare to the active ingredient of Imodium ® A-D children's For Ages 6 Years and Up Anti-Diarrheal Loperamide Hydrochloride Oral Solution, USP 1 mg per 7.5 mL Controls the symptoms of diarrhea Mint Flavor 4 fl oz (120 mL) image01"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-diarrheal"],"questions":["Questions or comments? call toll-free 1-888-235-2466"],"set_id":"4db35031-f765-39a6-e063-6394a90a40c9","spl_product_data_elements":["Loperamide Hydrochloride Loperamide Hydrochloride ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM CARAMEL PROPYLENE GLYCOL WATER DIMETHICONE SODIUM BENZOATE SUCRALOSE TITANIUM DIOXIDE XANTHAN GUM LOPERAMIDE HYDROCHLORIDE LOPERAMIDE flavadew coolmint"],"spl_unclassified_section":["Drug Facts","Do not use if outer neck band is broken or missing PEEL OPEN TO READ COMPLETE DIRECTIONS AND WARNINGS BEFORE PURCHASE *This product is not manufactured or distributed by the owners of Imodium ® A-D. DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 MADE IN INDIA 100% Satisfaction Guaranteed! (888) 309-9030 984006960 L0001226 R0226 A1791 Code: TN/Drugs/TN00002222/2006"],"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."],"storage_and_handling":["Other information each 30 mL contains: sodium 7 mg store at 20°C to 25°C (68°F to 77°F) do not use if outer neck band is broken or missing."],"version":"1","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 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. 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)"],"when_using":["When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery."]}