{"active_ingredient":["Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg"],"ask_doctor":["Ask a doctor before use if you have fever mucus in the stool a history of liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking antibiotics"],"do_not_use":["Do not use if you have bloody or black stool"],"dosage_and_administration":["Directions Use as directed per healthcare professional. 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 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 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
children 9-11 years (60-95 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
children 6-8 years (48-59 lbs)15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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":"20250627","id":"73a0214b-3f58-4357-ab53-314111602166","inactive_ingredient":["Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum"],"indications_and_usage":["Use controls symptoms of diarrhea, including Travelers' Diarrhea Read complete directions and warnings before using."],"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":["ANDA091292"],"brand_name":["Loperamide Hydrochloride"],"generic_name":["LOPERAMIDE HYDROCHLORIDE"],"manufacturer_name":["Precision Dose, Inc."],"original_packager_product_ndc":["0113-1645"],"package_ndc":["68094-029-59","68094-029-62","68094-129-59","68094-129-62"],"product_ndc":["68094-029","68094-129"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1250685"],"spl_id":["73a0214b-3f58-4357-ab53-314111602166"],"spl_set_id":["ae8237f0-95a6-4163-b476-25c0509ef151"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1 mg/7.5 mL Cup Lid Label NDC 68094-029-59 PrecisionDose™ LOPERAMIDE Hydrochloride Oral SOLUTION 1 mg/7.5 mL Shake Well Delivers 7.5 mL Gluten Free Contains 3.75 mg Sodium Hospital Use Only Store at 20°-25°C (68°-77°F) Pkg. By: Precision Dose, Inc. S. Beloit, IL 61080 1252 R1 PRINCIPAL DISPLAY PANEL - 1 mg/7.5 mL Cup Lid Label","PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label NDC 68094-129-59 PrecisionDose™ LOPERAMIDE Hydrochloride Oral SOLUTION 2 mg/15 mL Shake Well Delivers 15 mL Gluten Free Contains 7.5 mg Sodium Hospital Use Only Store at 20°-25°C (68°-77°F) Pkg. By: Precision Dose, Inc. S. Beloit, IL 61080 1253 R1 PRINCIPAL DISPLAY PANEL - 2 mg/15 mL Cup Lid Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-diarrheal"],"questions":["For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com"],"set_id":"ae8237f0-95a6-4163-b476-25c0509ef151","spl_product_data_elements":["Loperamide Hydrochloride Loperamide Hydrochloride Loperamide Hydrochloride Loperamide anhydrous citric acid carboxymethylcellulose sodium, unspecified D&C Yellow No. 10 FD&C Blue No. 1 Glycerin Microcrystalline cellulose propylene glycol water sodium benzoate sucralose titanium dioxide xanthan gum dimethicone silicon dioxide opaque, viscous Loperamide Hydrochloride Loperamide Hydrochloride Loperamide Hydrochloride Loperamide anhydrous citric acid carboxymethylcellulose sodium, unspecified D&C Yellow No. 10 FD&C Blue No. 1 Glycerin Microcrystalline cellulose propylene glycol water sodium benzoate sucralose titanium dioxide xanthan gum dimethicone silicon dioxide opaque, viscous"],"spl_unclassified_section":["Mint Flavor 1 mg/7.5 mL 2 mg/15 mL For Hospital Use Only","Drug Facts","Gluten Free","How Supplied NDC 68094-029-62 7.5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-129-62 15 mL per unit dose cup Thirty (30) cups per shipper","Distributed By Perrigo Company Allegan, MI 49010 Packaged By Precision Dose, Inc. South Beloit, IL 61080","LI1251 Rev. 04/22"],"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 15 mg store between 20-25°C (68-77°F)"],"version":"4","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 Ask a doctor or pharmacist before use if you are taking antibiotics 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."]}