{ "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 2mg Loperamide Hydrochloride Tablets USP, 2mg Loperamide Hydrochloride Loperamide carnauba wax SILICON DIOXIDE croscarmellose sodium HYDROXYPROPYL METHYLCELLULOSE lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol titanium dioxide white to off-white L;2" ], "active_ingredient": [ "ACTIVE INGREDIENT(S) Active ingredient (in each tablet) Loperamide HCl USP, 2 mg" ], "purpose": [ "PURPOSE Purpose Anti-diarrheal" ], "indications_and_usage": [ "USE(S) Use controls symptoms of diarrhea, including Travelers' Diarrhea" ], "warnings": [ "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": [ "DO NOT USE Do not use if you have bloody or black stool" ], "ask_doctor": [ "ASK A DOCTOR BEFORE USE IF 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 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 When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery." ], "stop_use": [ "STOP USE AND ASK DOCTOR IF 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": [ "PREGNANCY/BREASTFEEDING If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "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 Direction s • 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; ½ tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; ½ tablet after each subsequent loose stool; but no more than 2 tablets 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 over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; ½ tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; ½ tablet after each subsequent loose stool; but no more than 2 tablets 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
" ], "storage_and_handling": [ "STORAGE Other information • store at 20°-25°C (68°-77°F) • do not use if carton or blister unit is open or torn • FDA approved dissolution test specifications differ from USP" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide." ], "spl_unclassified_section": [ "QUESTIONS OR COMMENTS? Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM) Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735 Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa-403722 MADE IN INDIA" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL NDC: 25000-001-83 Loperamide Hydrochloride Tablets USP, 2mg 24's count blister carton loperamide-hcl-tablets-24ct-blister-carton" ], "set_id": "644fb37a-1d97-4333-a5c7-5a485ab338f7", "id": "2081729a-e6bb-44b8-8295-b7810b77df5e", "effective_time": "20251119", "version": "3", "openfda": { "application_number": [ "ANDA220153" ], "brand_name": [ "Loperamide Hydrochloride 2mg" ], "generic_name": [ "LOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MG" ], "manufacturer_name": [ "MARKSANS PHARMA LIMITED" ], "product_ndc": [ "25000-001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOPERAMIDE HYDROCHLORIDE" ], "rxcui": [ "978010" ], "spl_id": [ "2081729a-e6bb-44b8-8295-b7810b77df5e" ], "spl_set_id": [ "644fb37a-1d97-4333-a5c7-5a485ab338f7" ], "package_ndc": [ "25000-001-83" ], "is_original_packager": [ true ], "upc": [ "0325000001834" ], "unii": [ "77TI35393C" ] } } ] }