{ "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": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Pain Reliever Acetaminophen 500mg, film-coated caplet POVIDONE K30 ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN PALMITOSTEARIC ACID capsule-shaped biconvex N79 white to off-white Extra Strength Pain Reliever, Caseys 4good Acetaminophen 500mg, film-coated caplet ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN PALMITOSTEARIC ACID POVIDONE K30 capsule-shaped biconvex N79 white to off-white" ], "spl_unclassified_section": [ "Drug Facts", "**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets." ], "active_ingredient": [ "Active ingredient Active ingredient (in each caplet) Acetaminophen USP 500 mg" ], "purpose": [ "Purpose Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever" ], "warnings": [ "Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. Overdose warning Overdose warning: In case of overdose, get Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "stop_use": [ "Stop use and ask a doctor if Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present. These could 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." ], "overdosage": [ "Overdose warning Overdose warning: In case of overdose, get Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions Directions do not take more than directed (see ​Overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctor
children under 12 years
" ], "storage_and_handling": [ "Other information Other information store between 20° to 25°C (68° to 77°F)" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients povidone, pregelatinized starch (maize), stearic acid" ], "questions": [ "Questions Questions or comments? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)" ], "package_label_principal_display_panel": [ "Extra Strength Pain Reliever, Lil' Drug Store, 50ct PDP/Package [caduceus] Compare to the Active Ingredient in Tylenol® Extra Strength Caplets** Extra Strength Pain Reliever Acetaminophen 500 mg Pain Reliever/Fever Reducer [caplet image] ACTUAL SIZE 50Caplets [Lil' Drug Store logo] PDP/Package", "Extra Strength Pain Reliever, Casey's 4good, 50ct PDP/Package EXTRA STRENGTH Pain Reliever Acetaminophen 500 mg Pain Reliever/Fever Reducer Compare to the active ingredient in Tylenol® Extra Strength* [caplet image] actual size [ Casey's 4good logo TM ] 50 CAPLETS PDP/Package" ], "set_id": "e5fc5340-c224-e02b-e053-2a95a90a5297", "id": "2969c6e6-7fee-195e-e063-6294a90a268f", "effective_time": "20241216", "version": "3", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Extra Strength Pain Reliever, Caseys 4good", "Pain Reliever" ], "generic_name": [ "ACETAMINOPHEN 500MG, FILM-COATED CAPLET" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-6321", "66715-6871" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "198440" ], "spl_id": [ "2969c6e6-7fee-195e-e063-6294a90a268f" ], "spl_set_id": [ "e5fc5340-c224-e02b-e053-2a95a90a5297" ], "package_ndc": [ "66715-6871-4", "66715-6321-4" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }