{ "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": "2026-05-12", "results": { "skip": 0, "limit": 1, "total": 122 } }, "results": [ { "spl_product_data_elements": [ "Extra Strength Headache, Caseys 4good acetaminophen, aspirin, caffeine tablet CAFFEINE CAFFEINE SILICON DIOXIDE ACETAMINOPHEN ACETAMINOPHEN TALC HYPROMELLOSE, UNSPECIFIED ASPIRIN ASPIRIN POVIDONE K30 STARCH, CORN STEARIC ACID POLYETHYLENE GLYCOL, UNSPECIFIED MICROCRYSTALLINE CELLULOSE (capsule shaped, biconvex) S53" ], "spl_unclassified_section": [ "Drug Facts ​Drug Facts", "Other information Other information store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C) avoid excessive heat and humidity each caplet contains: Magnesium 0.58 mg" ], "active_ingredient": [ "Active ingredients Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin ( NSAID *) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ], "purpose": [ "Purpose ​Purposes Pain reliever Pain reliever Pain reliever aid" ], "indications_and_usage": [ "Uses Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps" ], "warnings": [ "Warnings ​Warnings Reye’s syndrome Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Acetaminophen 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. Allergy alert: Aspirin Allergy alert: Aspirin (NSAIDs) may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Stomach bleeding warning Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. Do not use Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear These could be signs of a serious condition If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 (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 Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "ask_doctor": [ "Ask a doctor before use if Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition" ], "stop_use": [ "Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear These could be signs of a serious condition" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." ], "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 (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 Directions do not use more than directed drink a full glass of water with each dose adults and children (12 years and over) take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours children under 12 years ask a doctor" ], "dosage_and_administration_table": [ "
adults and children (12 years and over)take 2 caplets every 6 hours as needed; not more than 8 caplets in 24 hours
children under 12 yearsask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc" ], "questions": [ "Questions or comments? Questions or comments? Call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)" ], "recent_major_changes": [ "" ], "package_label_principal_display_panel": [ "Extra Strength Headache, 6ct Casey's 4good TM Compare to the active ingredients in Excedrin Extra Strength ** EXTRA STRENGTH Headache Acetaminophen 250 mg Pain Reliever Aspirin (NSAID*) 250 mg Pain Reliever Caffeine 65 mg Pain Reliever Aid [Casey's logo] [caplet image] actual size 6 CAPLETS PDP/Package" ], "set_id": "0425c6a8-a3ea-24ad-e063-6294a90ae15a", "id": "2969de2e-dde5-8daa-e063-6394a90a5009", "effective_time": "20241216", "version": "2", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Extra Strength Headache, Caseys 4good" ], "generic_name": [ "ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-6338" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "ASPIRIN", "CAFFEINE" ], "rxcui": [ "308297" ], "spl_id": [ "2969de2e-dde5-8daa-e063-6394a90a5009" ], "spl_set_id": [ "0425c6a8-a3ea-24ad-e063-6294a90ae15a" ], "package_ndc": [ "66715-6338-3" ], "original_packager_product_ndc": [ "68210-4094" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]", "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]", "Xanthines [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "unii": [ "362O9ITL9D", "R16CO5Y76E", "3G6A5W338E" ] } } ] }