{ "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": [ "Anti-Diarrheal Loperamide HCI POWDERED CELLULOSE D&C YELLOW NO. 10 CROSCARMELLOSE SODIUM CROSPOVIDONE (15 MPA.S AT 5%) FD&C BLUE NO. 1 HYDROGENATED COTTONSEED OIL MAGNESIUM STEARATE STARCH, CORN ANHYDROUS LACTOSE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 123" ], "spl_unclassified_section": [ "Drug Facts", "Warnings Allergy alert Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl. Heart alert 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)", "*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Divison, distributor of Imodium® A-D Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404" ], "active_ingredient": [ "Active Ingredient ( in each tablet) Loperamide HCl, USP 2 mg" ], "purpose": [ "Purpose Anti-diarrheal" ], "indications_and_usage": [ "Use Controls symptoms of diarrhea, including Travelers’ Diarrhea" ], "warnings": [ "Allergy alert Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl." ], "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 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. 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 hour 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 - 47 lbs) ask a doctor children under 2 (up to 33 lbs) do not use" ], "dosage_and_administration_table": [ "
adults and children 12 years and over2 caplets after the first loose stool;1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hour
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 - 47 lbs)ask a doctor
children under 2(up to 33 lbs)do not use
" ], "storage_and_handling": [ "Other Information Other information ■ store between 68-77°F (20-25°C)" ], "inactive_ingredient": [ "Inactive Ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow no. 10 aluminum lake, FD&C Blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch" ], "questions": [ "Questions or Comments? Call 1-800-351-2000 (8:30 AM - 5:00 PM CST)" ], "package_label_principal_display_panel": [ "2 mg Loperamide Tablet Compare to the active ingredient in Imodium® A-D* Diamode Anti-Diarrheal Relief Loperamide HCl Tablets, USP 2 mg [tablet image] actual size 1 CAPLET IN EACH PACKET READ DRUG FACTS AND INSTRUCTIONS ON PACKET Anti Diarrheal Relief 1 Caplet in each pouch" ], "set_id": "eec84fa1-262f-6e77-e053-2995a90a325b", "id": "2a761ab3-5c89-92c0-e063-6294a90a93aa", "effective_time": "20241229", "version": "4", "openfda": { "application_number": [ "ANDA074091" ], "brand_name": [ "Anti-Diarrheal" ], "generic_name": [ "LOPERAMIDE HCI" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "29485-9286" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE" ], "rxcui": [ "978010" ], "spl_id": [ "2a761ab3-5c89-92c0-e063-6294a90a93aa" ], "spl_set_id": [ "eec84fa1-262f-6e77-e053-2995a90a325b" ], "package_ndc": [ "29485-9286-2", "29485-9286-3" ], "is_original_packager": [ true ], "unii": [ "77TI35393C" ] } } ] }