{ "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": [ "SED-MAX Acetaminophen 500 mg with Caffeine 65mg ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE STARCH, CORN CROSCARMELLOSE CROSPOVIDONE D&C RED NO. 27 ALUMINUM LAKE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSES MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE AZ;029" ], "active_ingredient": [ "Active ingredient(s) Acetaminophen 500mg Caffeine 65mg" ], "purpose": [ "Purpose Pain reliever/fever reducer Pain reliever aid" ], "indications_and_usage": [ "Uses temporary relief of minor aches and pains due to: ■ headache ■ muscular aches" ], "warnings": [ "Warnings 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 ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using this product 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. 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 heart beat. Do not use ■ if you are allergic to acetaminophen ■ with other products 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 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 ■ any new symptoms occur ■ painful area is red or swollen ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days These could be signs of a serious skin condition 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. 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 ■ if you are allergic to acetaminophen ■ with other products 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 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 ■ any new symptoms occur ■ painful area is red or swollen ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days These could be signs of a serious skin 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 (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 use more than directed ■ Adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours ■ Children under 12 years of age: ask a doctor" ], "spl_unclassified_section": [ "Other information ■ store at 20-25C (68-77F) ■ do not use if imprinted safety seal under cap is broken or missing ■you may report side effects to 1-888-952-0050" ], "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide" ], "package_label_principal_display_panel": [ "Principal Display Panel Sedmax Sedmax" ], "set_id": "4920a0e9-6f88-4df0-8657-77c95a3b9617", "id": "bd14fe1d-1a3f-4854-aab9-dbcd09046365", "effective_time": "20170119", "version": "4", "openfda": { "application_number": [ "M013" ], "brand_name": [ "SED-MAX" ], "generic_name": [ "ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG" ], "manufacturer_name": [ "Command Brands, LLC" ], "product_ndc": [ "69197-029" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CAFFEINE" ], "rxcui": [ "307686", "1866143" ], "spl_id": [ "bd14fe1d-1a3f-4854-aab9-dbcd09046365" ], "spl_set_id": [ "4920a0e9-6f88-4df0-8657-77c95a3b9617" ], "package_ndc": [ "69197-029-20" ], "is_original_packager": [ true ], "nui": [ "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_epc": [ "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "pharm_class_pe": [ "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Xanthines [CS]" ], "unii": [ "362O9ITL9D", "3G6A5W338E" ] } } ] }