{"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 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":["
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 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
"],"effective_time":"20260630","id":"52e6ecd3-7e31-a74b-e063-6294a90ab15c","inactive_ingredient":["Inactive ingredients anhydrous citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavadew coolmint flavor, 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":["Uses 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"],"manufacturer_name":["Kesin Pharma Corporation"],"original_packager_product_ndc":["69452-405"],"package_ndc":["81033-067-07","81033-067-34","81033-067-15","81033-067-35"],"product_ndc":["81033-067"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1250685"],"spl_id":["52e6ecd3-7e31-a74b-e063-6294a90ab15c"],"spl_set_id":["52e6ecc5-5f3d-9989-e063-6294a90af2dc"],"substance_name":["LOPERAMIDE HYDROCHLORIDE"],"unii":["77TI35393C"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 81033-067-34 Loperamide Hydrochloride Oral Solution, USP 1 mg per 7.5 mL Delivers 7.5 mL 30 x 7.5 mL Unit Dose Cups Loperamide OS 7.5 mL Carton","NDC 81033-067-35 Loperamide Hydrochloride Oral Solution, USP 2 mg per 15 mL Delivers 15 mL 20 x 15 mL Unit Dose Cups Loperamide OS 15 mL Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Anti-Diarrheal"],"questions":["Questions or comments? Call 1-616-218-2725"],"set_id":"52e6ecc5-5f3d-9989-e063-6294a90af2dc","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 light green opaque"],"spl_unclassified_section":["*This product is not manufactured or distributed by the owners of Imodium ®A-D. Distributed by: Kesin Pharma Oldsmar, FL 34677 PIS-067-V01 Rev. 05/2026 Kesin Pharma Logo"],"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) Loperamide HCl Oral Solution is a light green opaque, cool mint flavored solution supplied in the following: NDC 81033-067-07: 7.5 mL unit-dose cup NDC 81033-067-34: Carton containing 30 unit-dose cups of 7.5 mL each NDC 81033-067-15: 15 mL unit-dose cup NDC 81033-067-35: Carton containing 30 unit-dose cups of 15 mL each"],"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."]}