{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Pain Reliever acetaminophen tablet, extra strength ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED STEARIC ACID TITANIUM DIOXIDE HYPROMELLOSE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A CORN AZ;235" ], "spl_unclassified_section": [ "Drug Facts", "Other information Other information do not use if vial is open or damaged store at 59-86˚F (15-30˚C)" ], "active_ingredient": [ "Active ingredient (in each tablet) Acetaminophen 500mg" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "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 Warnings Liver warning Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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 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 before use if you are taking the blood thinning drug warfarin 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 Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 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 before use if you are taking the blood thinning drug warfarin" ], "stop_use": [ "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 Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets 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 ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 12 years and overtake 2 tablets every 6 hours while symptoms lastdo not take more than 6 tablets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients corn starch, hypromellose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide" ], "questions": [ "Questions or comments? call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)" ], "package_label_principal_display_panel": [ "Extra Strength Pain Reliever Acetaminophen, 500 mg Pain Reliever/Fever Reducer 10 Tablets [Lil' Drug Store ® logo] PDP/Package" ], "set_id": "f0fdab5a-9d07-57aa-e053-2a95a90adc7f", "id": "0c8f99ae-73a5-7ac4-e063-6294a90a0f36", "effective_time": "20231215", "version": "2", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Pain Reliever" ], "generic_name": [ "ACETAMINOPHEN TABLET, EXTRA STRENGTH" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-9637" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "198440" ], "spl_id": [ "0c8f99ae-73a5-7ac4-e063-6294a90a0f36" ], "spl_set_id": [ "f0fdab5a-9d07-57aa-e053-2a95a90adc7f" ], "package_ndc": [ "66715-9637-4" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }