{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Loperamide Hydrochloride Loperamide Hydrochloride oral 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. Code: TN/Drugs/TN00002222/2006 L0001188 R1125 948006945 Distributed by: BIONPHARMA INC. Princeton, NJ 08540 MADE IN INDIA" ], "active_ingredient": [ "Active ingredient (in each 7.5 mL) Loperamide HCl, USP 1 mg" ], "purpose": [ "Purpose Anti-diarrheal" ], "indications_and_usage": [ "Use controls symptoms of diarrhea, including Travelers' Diarrhea" ], "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)" ], "do_not_use": [ "Do not use if you have bloody or black stool" ], "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." ], "when_using": [ "When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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)" ], "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": [ "
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
" ], "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." ], "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" ], "questions": [ "Questions or comments? call toll-free 1-888-235-2466" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL-8 fl oz *Compare to the active ingredient in Imodium ® A-D a+ health TM Loperamide HCl Oral Solution, USP 1 mg per 7.5 mL Anti-Diarrheal Oral Solution Controls the symptoms of diarrhea Mint Flavor 8 fl oz (240 mL) image001-ad image002-ad image003-ad", "PRINCIPAL DISPLAY PANEL-4 fl oz * Compare to the active ingredient in Imodium ®A-D a+ health TM for ages 6 years & up Loperamide HCl Oral Solution, USP 1 mg per 7.5 mL Anti-Diarrheal Oral Solution Controls the symptoms of diarrhea Mint Flavor 4 fl oz (120 mL) image001-ch image002-ch image003-ch" ], "set_id": "4bd0939e-c172-d962-e063-6394a90a44b5", "id": "4bd07c07-575e-1543-e063-6294a90a9b3c", "effective_time": "20260227", "version": "1", "openfda": { "application_number": [ "ANDA220100" ], "brand_name": [ "Loperamide Hydrochloride" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE ORAL" ], "manufacturer_name": [ "Bionpharma Inc." ], "product_ndc": [ "69452-405" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE" ], "rxcui": [ "1250685" ], "spl_id": [ "4bd07c07-575e-1543-e063-6294a90a9b3c" ], "spl_set_id": [ "4bd0939e-c172-d962-e063-6394a90a44b5" ], "package_ndc": [ "69452-405-55", "69452-405-93" ], "is_original_packager": [ true ], "upc": [ "0369452405932", "0369452405550" ], "unii": [ "77TI35393C" ] } } ] }