Acetaminophen

Acetaminophen tablet extended release · Tablet · Oral, Intravenous, Rectal

Over the counter Nonsteroidal Anti-inflammatory Drug 10 recalls

Boxed warning. WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death [ see Warnings and Precautions (5.3) ]. In particular, be careful to ensure that: the dose in milligrams (mg) and milliliters (mL) is not confused; the dosing is based on weight for patients under 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits. Acetaminophen Injection contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one…

Uses

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older. the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. the reduction of fever in adult and pediatric patients. Acetaminophen Injection is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older. ( 1 ) Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. ( 1 ) Reduction of fever in adult and pediatric patients. ( 1 )

Dosage and administration

Acetaminophen Injection may be given as a single or repeated dose. ( 2.1 ) Acetaminophen Injection should be administered only as a 15-minute intravenous infusion. ( 2.5 ) Adults and Adolescents Weighing 50 kg and Over: 1,000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4,000 mg per day. Minimum dosing interval of 4 hours. ( 2.2 ) Adults and Adolescents Weighing Under 50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours. ( 2.2 ) Children: Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours. ( 2.3 ) Neonates and Infants: Neonates including premature neonates born at greater than or equal to 32 weeks gestational age to 28 days chronological age, 12.5 mg/kg every 6 hours to a maximum of 50 mg/kg per day. Minimum dosing interval of 6 hours. ( 2.4 ) Infants (29 days to 2 years of age): 15 mg/kg every 6 hours to a maximum of 60 mg/kg per day. Minimum dosing interval of 6 hours. ( 2.4 ) 2.1 Important Dosage and Administration Instructions Acetaminophen Injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and Acetaminophen Injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen. Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1-3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose. 2.2 Recommended Dosage: Adults and Adolescents Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen Injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4,000 mg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Table 1. Dosing for Adults and Adolescents Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Adults and adolescents (13 years and older) weighing greater than or equal to 50 kg 650 mg 1,000 mg 1,000 mg 4,000 mg in 24 hours Adults and adolescents (13 years and older) weighing less than 50 kg 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3,750 mg) 2.3 Recommended Dosage: Children Children 2 to 12 years of age: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen Injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day. Table 2. Dosing for Children Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3,750 mg) 2.4 Recommended Dosage for Treatment of Fever in Neonates and Infants Neonates, including premature neonates born at greater than or equal to 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of Acetaminophen Injection is 12.5 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 50 mg/kg per day, with a minimum dosing interval of 6 hours. Infants 29 days to 2 years of age: the recommended dosage of Acetaminophen Injection is 15 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 60 mg/kg per day, with a minimum dosing interval of 6 hours. Table 3. Dosing for Treatment of Fever in Neonates and Infants Age group Dose given every 6 hours Maximum total daily dose of acetaminophen (by all routes) Neonates (birth to 28 days) 12.5 mg/kg 50 mg/kg Infants (29 days to 2 years) 15 mg/kg 60 mg/kg 2.5 Instructions for Intravenous Administration For adult and adolescent patients weighing greater than or equal to 50 kg requiring 1,000 mg doses of Acetaminophen Injection, administer by intravenous infusion. Acetaminophen Injection may be administered without further dilution. Examine the bag contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired. Keep the infusion bags in the overwrap until ready to use. Administer the contents of the bag intravenously over 15 minutes. Use aseptic technique when preparing Acetaminophen Injection for intravenous infusion. Do not add other medications to the Acetaminophen Injection bag or infusion device. For doses less than 1,000 mg, the appropriate dose must be withdrawn from the bag and placed into a separate container prior to administration .

Label text from the FDA structured product label by Hikma Pharmaceuticals USA Inc. (revised Aug 18, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Acetaminophen in 258 products
Ibuprofen in 1 product

Acetaminophen NDC products (258)

NDC	Strength & form	Labeler	Type
50090-0001	Acetaminophen 120 mg/1 Suppository	A-S Medication Solutions	ANDA
60687-924	Acetaminophen 650 mg/1 Tablet	American Health Packaging	ANDA
76420-914	Acetaminophen 650 mg/1 Tablet, Extended Release	Asclemed USA, Inc.	ANDA
58602-873	Acetaminophen 650 mg/1 Tablet, Extended Release	Aurohealth LLC	ANDA
58602-848	Acetaminophen 650 mg/1 Tablet, Extended Release	Aurohealth LLC	ANDA
58602-730	Acetaminophen 650 mg/1 Tablet, Extended Release	Aurohealth LLC	ANDA
36000-306	Acetaminophen 10 mg/mL Injection, Solution	Baxter Healthcare Corporation	ANDA
36000-372	Acetaminophen 10 mg/mL Injection, Solution	Baxter Healthcare Corporation	ANDA
21130-108	Acetaminophen 650 mg/1 Tablet, Extended Release	Better Living Brands, LLC	ANDA
37835-512	Acetaminophen 650 mg/1 Tablet, Extended Release	Bi-Mart	ANDA
68001-495	Acetaminophen 650 mg/1 Tablet	BluePoint Laboratories	ANDA
71335-1340	Acetaminophen 650 mg/1 Tablet, Extended Release	Bryant Ranch Prepack	ANDA
71335-9746	Acetaminophen 650 mg/1 Tablet, Extended Release	Bryant Ranch Prepack	ANDA
31722-205	Acetaminophen 10 mg/mL Injection, Solution	Camber Pharmaceuticals, Inc.	ANDA
65145-157	Acetaminophen 10 mg/mL Injection, Solution	Caplin Steriles Limited	ANDA
63868-660	Acetaminophen 650 mg/1 Tablet, Extended Release	CHAIN DRUG MARKETING ASSOCIATION INC	ANDA
72572-050	Acetaminophen 10 mg/mL Injection, Solution	Civica, Inc.	ANDA
69842-930	Acetaminophen 650 mg/1 Tablet, Extended Release	CVS Pharmacy	ANDA
69842-297	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	CVS PHARMACY iNC	ANDA
69842-322	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	CVS PHARMACY INC	ANDA
69842-635	Acetaminophen 650 mg/1 Tablet, Extended Release	CVS Pharmacy, Inc.	ANDA
69842-037	Acetaminophen 650 mg/1 Tablet, Extended Release	CVS Pharmacy, Inc.	ANDA
55150-307	Acetaminophen 10 mg/mL Injection, Solution	Eugia US LLC	ANDA
55319-185	Acetaminophen 650 mg/1 Tablet	FAMILY DOLLAR	ANDA
57896-268	Acetaminophen 650 mg/1 Tablet, Extended Release	GERI-CARE PHARMACEUTICAL CORP	ANDA
68083-648	Acetaminophen 10 mg/mL Injection, Solution	Gland Pharma Limited	ANDA
68083-647	Acetaminophen 10 mg/mL Injection, Solution	Gland Pharma Limited	ANDA
62207-183	Acetaminophen 650 mg/1 Tablet, Extended Release	Granules India Limited	ANDA
62207-188	Acetaminophen 650 mg/1 Tablet, Extended Release	Granules India Limited	ANDA
62207-892	Acetaminophen 650 mg/1 Tablet, Extended Release	Granules India Limited	ANDA
70010-160	Acetaminophen 650 mg/1 Tablet, Extended Release	Granules Pharmaceuticals Inc.	ANDA
69848-015	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	Granules USA, Inc.	ANDA
51662-1540	Acetaminophen 10 mg/mL Injection, Solution	HF Acquisition Co LLC, DBA HealthFirst	ANDA
24201-100	Acetaminophen 10 mg/mL Injection, Solution	Hikma Pharmaceuticals USA Inc.	ANDA
24201-110	Acetaminophen 10 mg/mL Injection, Solution	Hikma Pharmaceuticals USA Inc.	ANDA
30142-157	Acetaminophen 650 mg/1 Tablet, Extended Release	KROGER COMPANY	ANDA
70000-0627	Acetaminophen 650 mg/1 Tablet	LEADER/ Cardinal Health 110, Inc	ANDA
70000-0626	Acetaminophen 650 mg/1 Tablet	LEADER/ Cardinal Health 110, Inc	ANDA
0904-7314	Acetaminophen 650 mg/1 Tablet	MAJOR PHARMACEUTICALS	ANDA
53329-643	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	Medline Industries, LP	ANDA
79481-0183	Acetaminophen 650 mg/1 Tablet	MEIJER DISTRIBUTION INC	ANDA
79481-0184	Acetaminophen 650 mg/1 Tablet	MEIJER, INC.	ANDA
67457-940	Acetaminophen 1000 mg/100mL Injection, Solution	Mylan Institutional LLC	ANDA
0615-8624	Acetaminophen 650 mg/1 Tablet, Extended Release	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA
68071-4151	Acetaminophen 120 mg/1 Suppository	NuCare Pharmaceutiacals,Inc.	ANDA
68071-4172	Acetaminophen 120 mg/1 Suppository	NuCare Pharmaceuticals,Inc.	ANDA
45802-732	Acetaminophen 120 mg/1 Suppository	Padagis Israel Pharmaceuticals Ltd	ANDA
45802-730	Acetaminophen 650 mg/1 Suppository	Padagis Israel Pharmaceuticals Ltd	ANDA
63187-373	Acetaminophen 120 mg/1 Suppository	Proficient Rx LP	ANDA
70038-131	Acetaminophen 250 mg/1; Ibuprofen 125 mg/1 Tablet	RAONBIO CORP	ANDA
70518-4184	Acetaminophen 10 mg/mL Injection, Solution	REMEDYREPACK INC.	ANDA
72476-185	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	RETAIL BUSINESS SERVICES,LLC.	ANDA
72476-186	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	RETAIL BUSINESS SERVICES,LLC.	ANDA
11822-5091	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	RITE AID	ANDA
11822-5019	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	RITE AID	ANDA
25021-705	Acetaminophen 10 mg/mL Injection, Solution	Sagent Pharmaceuticals	ANDA
68196-935	Acetaminophen 650 mg/1 Tablet	SAM'S WEST INC	ANDA
0781-3156	Acetaminophen 10 mg/mL Injection, Solution	Sandoz Inc	ANDA
0781-9274	Acetaminophen 10 mg/mL Injection, Solution	Sandoz Inc	ANDA
55579-110	Acetaminophen 1000 mg/100mL Injection	Solupharm Pharmazeutische Erzeugnisse GmbH	ANDA
55579-405	Acetaminophen 10 mg/mL Injection, Solution	Solupharm Pharmazeutische Erzeugnisse GmbH	ANDA
70069-871	Acetaminophen 10 mg/mL Injection, Solution	Somerset Therapeutics, LLC	ANDA
49483-699	Acetaminophen 650 mg/1 Tablet, Extended Release	TIME CAP LABORATORIES, INC.	ANDA
49035-181	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	WAL-MART STORES INC	ANDA
79903-137	Acetaminophen 650 mg/1 Tablet	WAL-MART STORES INC	ANDA
0363-9604	Acetaminophen 650 mg/1 Tablet, Extended Release	WALGREEN CO.	ANDA
0363-0340	Acetaminophen 650 mg/1 Tablet, Extended Release	Walgreen Company	ANDA
0363-0892	Acetaminophen 650 mg/1 Tablet	Walgreens	ANDA
0363-9992	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	WALGREENS	ANDA
0363-9993	Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release	WALGREENS CO.	ANDA
79903-132	Acetaminophen 650 mg/1 Tablet, Extended Release	WALMART INC.	ANDA
44567-340	Acetaminophen 10 mg/mL Injection, Solution	WG Critical Care, LLC	ANDA
14803-013	Acetaminophen 325 mg/1 Tablet	Elysium Pharmaceuticals Ltd.	DRUG FOR FURTHER PROCESSING
14803-281	Acetaminophen 500 mg/1 Tablet	Elysium Pharmaceuticals Ltd.	DRUG FOR FURTHER PROCESSING
0264-4050	Acetaminophen 10 mg/mL Injection	B. Braun Medical Inc.	NDA
0264-4100	Acetaminophen 10 mg/mL Injection	B. Braun Medical Inc.	NDA
63323-434	Acetaminophen 10 mg/mL Injection	Fresenius Kabi USA, LLC	NDA
0143-9386	Acetaminophen 1000 mg/100mL Injection	Hikma Pharmaceuticals USA Inc.	NDA
84549-100	Acetaminophen 10 mg/mL Injection	ProPharma Distribution	NDA
50090-5350	Acetaminophen 500 mg/1 Tablet	A-S Medication Solutions	OTC MONOGRAPH DRUG
50090-5313	Acetaminophen 500 mg/1 Tablet	A-S Medication Solutions	OTC MONOGRAPH DRUG
50090-5272	Acetaminophen 500 mg/1 Tablet	A-S Medication Solutions	OTC MONOGRAPH DRUG
50090-6059	Acetaminophen 160 mg/5mL Liquid	A-S Medication Solutions	OTC MONOGRAPH DRUG
57344-004	Acetaminophen 500 mg/1 Tablet, Coated	AAA Pharmaceutical, Inc.	OTC MONOGRAPH DRUG
82568-0001	Acetaminophen 325 mg/1 Tablet	AARNA USA INC.	OTC MONOGRAPH DRUG
82568-0002	Acetaminophen 500 mg/1 Tablet	AARNA USA INC.	OTC MONOGRAPH DRUG
52343-555	Acetaminophen 160 mg/5mL Solution	Acetris Pharma Holdings, LLC	OTC MONOGRAPH DRUG
71399-1025	Acetaminophen 325 mg/1 Tablet	Akron Pharma Inc.	OTC MONOGRAPH DRUG
71399-1026	Acetaminophen 500 mg/1 Tablet	Akron Pharma Inc.	OTC MONOGRAPH DRUG
60687-751	Acetaminophen 325 mg/10.15mL Solution	American Health Packaging	OTC MONOGRAPH DRUG
60687-740	Acetaminophen 650 mg/20.3mL Solution	American Health Packaging	OTC MONOGRAPH DRUG
61504-104	Acetaminophen 500 mg/1 Tablet, Coated	AMERIFOODS TRADING COMPANY	OTC MONOGRAPH DRUG
46122-430	Acetaminophen 325 mg/1 Tablet, Coated	Amerisource Bergen	OTC MONOGRAPH DRUG
55301-175	Acetaminophen 500 mg/1 Tablet, Film Coated	ARMY AND AIR FORCE EXCHANGE SERVICE	OTC MONOGRAPH DRUG
55301-519	Acetaminophen 500 mg/1 Tablet, Coated	ARMY AND AIR FORCE EXCHANGE SERVICE	OTC MONOGRAPH DRUG
87063-222	Acetaminophen 500 mg/1 Tablet	ASCLEMED USA INC.	OTC MONOGRAPH DRUG
58602-773	Acetaminophen 500 mg/1 Tablet	Aurohealth LLC	OTC MONOGRAPH DRUG
58602-774	Acetaminophen 160 mg/1 Tablet	Aurohealth LLC	OTC MONOGRAPH DRUG
21130-353	Acetaminophen 500 mg/1 Tablet	BETTER LIVING BRANDS LLC.	OTC MONOGRAPH DRUG
21130-356	Acetaminophen 500 mg/1 Tablet	BETTER LIVING BRANDS LLC.	OTC MONOGRAPH DRUG
71335-2747	Acetaminophen 325 mg/1 Tablet	Bryant Ranch Prepack	OTC MONOGRAPH DRUG
71335-3130	Acetaminophen 325 mg/1 Tablet, Film Coated	Bryant Ranch Prepack	OTC MONOGRAPH DRUG
71335-2251	Acetaminophen 500 mg/1 Tablet	Bryant Ranch Prepack	OTC MONOGRAPH DRUG
71335-1536	Acetaminophen 500 mg/1 Tablet	Bryant Ranch Prepack	OTC MONOGRAPH DRUG
72162-2164	Acetaminophen 500 mg/1 Tablet	Bryant Ranch Prepack	OTC MONOGRAPH DRUG
72162-2163	Acetaminophen 500 mg/1 Tablet	Bryant Ranch Prepack	OTC MONOGRAPH DRUG
55154-7897	Acetaminophen 500 mg/1 Tablet	Cardinal Health 107, LLC	OTC MONOGRAPH DRUG
55154-7899	Acetaminophen 325 mg/1 Tablet	Cardinal Health 107, LLC	OTC MONOGRAPH DRUG
55154-9449	Acetaminophen 650 mg/20.3mL Solution	Cardinal Health 107, LLC	OTC MONOGRAPH DRUG
70000-0312	Acetaminophen 500 mg/1 Tablet, Coated	Cardinal Health 110, LLC. DBA Leader	OTC MONOGRAPH DRUG
63868-678	Acetaminophen 160 mg/5mL Suspension	CHAIN DRUG MARKETING ASSOCIATION INC	OTC MONOGRAPH DRUG
63868-677	Acetaminophen 160 mg/5mL Suspension	CHAIN DRUG MARKETING ASSOCIATION INC	OTC MONOGRAPH DRUG
63868-809	Acetaminophen 500 mg/15mL Syrup	CHAIN DRUG MARKETING ASSOCIATION INC.	OTC MONOGRAPH DRUG
63981-019	Acetaminophen 500 mg/1 Tablet, Coated	COSTCO WHOLESALE CORPORATION	OTC MONOGRAPH DRUG
69842-968	Acetaminophen 325 mg/1 Tablet	CVS HEALTH CORP	OTC MONOGRAPH DRUG
69842-931	Acetaminophen 500 mg/1 Tablet, Film Coated	CVS PHARMACY	OTC MONOGRAPH DRUG
69842-445	Acetaminophen 1000 mg/30mL Solution	CVS PHARMACY	OTC MONOGRAPH DRUG
69842-915	Acetaminophen 500 mg/1 Tablet, Coated	CVS PHARMACY	OTC MONOGRAPH DRUG
69842-876	Acetaminophen 325 mg/1 Tablet, Coated	CVS PHARMACY	OTC MONOGRAPH DRUG
69842-750	Acetaminophen 500 mg/1 Tablet, Film Coated	CVS PHARMACY	OTC MONOGRAPH DRUG
69842-484	Acetaminophen 500 mg/1 Tablet	CVS Pharmacy	OTC MONOGRAPH DRUG
69842-298	Acetaminophen 500 mg/1 Tablet	CVS PHARMACY, INC	OTC MONOGRAPH DRUG
51316-177	Acetaminophen 500 mg/1 Tablet	CVS PHARMACY, INC	OTC MONOGRAPH DRUG
69842-295	Acetaminophen 500 mg/1 Tablet	CVS PHARMACY, INC	OTC MONOGRAPH DRUG
69842-864	Acetaminophen 500 mg/1 Tablet, Film Coated	CVS Pharmacy, Inc	OTC MONOGRAPH DRUG
69842-491	Acetaminophen 500 mg/1 Tablet	CVS PHARMACY, INC	OTC MONOGRAPH DRUG
51316-342	Acetaminophen 500 mg/1 Tablet, Film Coated	CVS Pharmacy, Inc.	OTC MONOGRAPH DRUG
69842-465	Acetaminophen 500 mg/1 Tablet	CVS Pharmacy, Inc.	OTC MONOGRAPH DRUG
51316-303	Acetaminophen 1000 mg/30mL Solution	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	OTC MONOGRAPH DRUG
75907-433	Acetaminophen 500 mg/1 Tablet	Dr. Reddy's Laboratories Inc.	OTC MONOGRAPH DRUG
75907-429	Acetaminophen 500 mg/1 Tablet	Dr. Reddy's Laboratories Inc.	OTC MONOGRAPH DRUG
55319-177	Acetaminophen 500 mg/1 Tablet	FAMILY DOLLAR	OTC MONOGRAPH DRUG
55319-751	Acetaminophen 500 mg/1 Tablet	Family Dollar, Inc.	OTC MONOGRAPH DRUG
41520-919	Acetaminophen 500 mg/1 Tablet, Coated	FOODHOLD U.S.A., LLC	OTC MONOGRAPH DRUG
81522-104	Acetaminophen 500 mg/1 Tablet, Coated	FSA Store Inc.	OTC MONOGRAPH DRUG
81522-070	Acetaminophen 500 mg/1 Tablet, Coated	FSA STORE INC.	OTC MONOGRAPH DRUG
70010-161	Acetaminophen 500 mg/1 Tablet	Granules Pharmaceuticals Inc.	OTC MONOGRAPH DRUG
69848-003	Acetaminophen 500 mg/1 Tablet	Granules USA, Inc	OTC MONOGRAPH DRUG
69848-008	Acetaminophen 500 mg/1 Tablet	Granules USA, Inc	OTC MONOGRAPH DRUG
85828-102	Acetaminophen 325 mg/1 Tablet	Grocery Outlet, Inc.	OTC MONOGRAPH DRUG
85828-170	Acetaminophen 500 mg/1 Tablet, Coated	Grocery Outlet, Inc.	OTC MONOGRAPH DRUG
72036-170	Acetaminophen 500 mg/1 Tablet, Coated	Harris Teeter	OTC MONOGRAPH DRUG
72036-104	Acetaminophen 500 mg/1 Tablet, Coated	HARRIS TEETER	OTC MONOGRAPH DRUG
72036-100	Acetaminophen 325 mg/1 Tablet	HARRIS TEETER	OTC MONOGRAPH DRUG
72036-098	Acetaminophen 500 mg/1 Tablet, Coated	HARRIS TEETER	OTC MONOGRAPH DRUG
72036-092	Acetaminophen 500 mg/1 Tablet, Coated	HARRIS TEETER	OTC MONOGRAPH DRUG
71679-305	Acetaminophen 325 mg/1 Tablet, Film Coated	Health Pharma USA LLC	OTC MONOGRAPH DRUG
51662-1665	Acetaminophen 325 mg/1 Tablet, Coated	HF Acquisition Co LLC, DBA HealthFirst	OTC MONOGRAPH DRUG
51662-1666	Acetaminophen .5 g/g Tablet	HF Acquisition Co LLC, DBA HealthFirst	OTC MONOGRAPH DRUG
69732-002	Acetaminophen 325 mg/1 Tablet	Hi-Tech Nutraceuticals, LLC	OTC MONOGRAPH DRUG
30142-561	Acetaminophen 500 mg/1 Tablet	Kroger Company	OTC MONOGRAPH DRUG
30142-507	Acetaminophen 500 mg/1 Tablet, Film Coated	Kroger Company	OTC MONOGRAPH DRUG
41226-341	Acetaminophen 500 mg/1 Tablet, Coated	Kroger Company	OTC MONOGRAPH DRUG
41226-697	Acetaminophen 500 mg/1 Tablet, Coated	Kroger Company	OTC MONOGRAPH DRUG
70000-0709	Acetaminophen 500 mg/1 Tablet	LEADER/ Cardinal Health 110, Inc.	OTC MONOGRAPH DRUG
70000-0036	Acetaminophen 500 mg/1 Tablet	LEADER/ Cardinal Health 110, Inc.	OTC MONOGRAPH DRUG
70000-0410	Acetaminophen 500 mg/1 Tablet	LEADER/ Cardinal Health 110, Inc.	OTC MONOGRAPH DRUG
0904-6730	Acetaminophen 500 mg/1 Tablet	Major Pharmaceuticals	OTC MONOGRAPH DRUG
0904-6720	Acetaminophen 500 mg/1 Tablet	Major Pharmaceuticals	OTC MONOGRAPH DRUG
0904-6773	Acetaminophen 325 mg/1 Tablet	Major Pharmaceuticals	OTC MONOGRAPH DRUG
0904-7481	Acetaminophen 1000 mg/30mL Solution	Major Pharmaceuticals	OTC MONOGRAPH DRUG
0904-7321	Acetaminophen 650 mg/20.3mL Solution	Major Pharmaceuticals	OTC MONOGRAPH DRUG
0904-7320	Acetaminophen 325 mg/10.15mL Solution	Major Pharmaceuticals	OTC MONOGRAPH DRUG
0904-7319	Acetaminophen 160 mg/5mL Solution	Major Pharmaceuticals	OTC MONOGRAPH DRUG
10135-829	Acetaminophen 500 mg/1 Tablet	Marlex Pharmaceuticals Inc	OTC MONOGRAPH DRUG
68599-4681	Acetaminophen .5 g/g Tablet	McKesson	OTC MONOGRAPH DRUG
79481-5380	Acetaminophen 500 mg/1 Tablet	Meijer	OTC MONOGRAPH DRUG
41250-570	Acetaminophen 500 mg/1 Tablet, Coated	MEIJER DISTRIBUTION INC	OTC MONOGRAPH DRUG
79481-0780	Acetaminophen 500 mg/1 Tablet	Meijer Distribution Inc	OTC MONOGRAPH DRUG
0615-8397	Acetaminophen 325 mg/1 Tablet	NCS HealthCare of KY, LLC dba Vangard Labs	OTC MONOGRAPH DRUG
0615-8398	Acetaminophen 325 mg/1 Tablet	NCS HealthCare of KY, LLC dba Vangard Labs	OTC MONOGRAPH DRUG
0615-8608	Acetaminophen 325 mg/1 Tablet, Film Coated	NCS HealthCare of KY, LLC dba Vangard Labs	OTC MONOGRAPH DRUG
0615-8610	Acetaminophen 500 mg/1 Tablet, Film Coated	NCS HealthCare of KY, LLC dba Vangard Labs	OTC MONOGRAPH DRUG
0615-8609	Acetaminophen 325 mg/1 Tablet, Film Coated	NCS HealthCare of KY, LLC dba Vangard Labs	OTC MONOGRAPH DRUG
68071-5300	Acetaminophen 500 mg/1 Tablet	NuCare Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
68071-3959	Acetaminophen 500 mg/1 Tablet	NuCare Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
68071-4860	Acetaminophen 160 mg/5mL Suspension	NuCare Pharmaceuticals,Inc.	OTC MONOGRAPH DRUG
68071-3437	Acetaminophen 500 mg/1 Tablet	NuCare Pharmaceuticals,Inc.	OTC MONOGRAPH DRUG
68071-3454	Acetaminophen 325 mg/1 Tablet	NuCare Pharmaceuticals,Inc.	OTC MONOGRAPH DRUG
68071-5239	Acetaminophen 500 mg/1 Tablet	NuCare Pharmaceuticals,Inc.	OTC MONOGRAPH DRUG
83720-500	Acetaminophen 160 mg/5mL Liquid	Oncor Pharmaceuticals	OTC MONOGRAPH DRUG
69729-028	Acetaminophen 160 mg/5mL Suspension	OPMX LLC	OTC MONOGRAPH DRUG
0121-0941	Acetaminophen 160 mg/5mL Suspension	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-0657	Acetaminophen 160 mg/5mL Solution	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-1047	Acetaminophen 160 mg/5mL Solution	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-1971	Acetaminophen 650 mg/20.3mL Solution	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-1882	Acetaminophen 325 mg/10.15mL Suspension	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-2094	Acetaminophen 325 mg/10.15mL Solution	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-3141	Acetaminophen 650 mg/20.3mL Solution	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-2823	Acetaminophen 650 mg/20.3mL Suspension	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
0121-1314	Acetaminophen 325 mg/10.15mL Solution	PAI Holdings, LLC dba PAI Pharma	OTC MONOGRAPH DRUG
72789-241	Acetaminophen 500 mg/1 Tablet	PD-Rx Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
55289-880	Acetaminophen 500 mg/1 Tablet	PD-Rx Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
55289-563	Acetaminophen 325 mg/1 Tablet	PD-Rx Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
72789-267	Acetaminophen 325 mg/1 Tablet	PD-Rx Pharmaceuticals, Inc.	OTC MONOGRAPH DRUG
68094-231	Acetaminophen 160 mg/5mL Suspension	Precision Dose, Inc.	OTC MONOGRAPH DRUG
68094-130	Acetaminophen 160 mg/5mL Suspension	Precision Dose, Inc.	OTC MONOGRAPH DRUG
68094-042	Acetaminophen 160 mg/5mL Suspension	Precision Dose, Inc.	OTC MONOGRAPH DRUG
68094-038	Acetaminophen 160 mg/5mL Suspension	Precision Dose, Inc.	OTC MONOGRAPH DRUG
68094-030	Acetaminophen 160 mg/5mL Suspension	Precision Dose, Inc.	OTC MONOGRAPH DRUG
68094-330	Acetaminophen 160 mg/5mL Suspension	Precision Dose, Inc.	OTC MONOGRAPH DRUG
68788-4132	Acetaminophen 500 mg/1 Tablet	Preferred Pharmaceuticals Inc.	OTC MONOGRAPH DRUG
68788-8559	Acetaminophen 500 mg/1 Tablet	Preferred Pharmaceuticals Inc.	OTC MONOGRAPH DRUG
68788-8636	Acetaminophen 500 mg/1 Tablet	Preferrred Pharmaceuticals Inc.	OTC MONOGRAPH DRUG
71205-730	Acetaminophen 160 mg/5mL Liquid	Proficient Rx LP	OTC MONOGRAPH DRUG
71205-165	Acetaminophen 500 mg/1 Tablet	Proficient Rx LP	OTC MONOGRAPH DRUG
58228-0061	Acetaminophen 325 mg/1 Tablet	Prostat First Aid	OTC MONOGRAPH DRUG
58228-1986	Acetaminophen 500 mg/1 Tablet	Prostat First Aid	OTC MONOGRAPH DRUG
41415-175	Acetaminophen 500 mg/1 Tablet	PUBLIX SUPERMARKETS, INC	OTC MONOGRAPH DRUG
41415-177	Acetaminophen 500 mg/1 Tablet	PUBLIX SUPERMARKETS, INC	OTC MONOGRAPH DRUG
41415-538	Acetaminophen 500 mg/1 Tablet	PUBLIX SUPERMARKETS, INC	OTC MONOGRAPH DRUG
72476-104	Acetaminophen 500 mg/1 Tablet, Coated	RETAIL BUSINESS SERVICES , LLC.	OTC MONOGRAPH DRUG
72476-070	Acetaminophen 500 mg/1 Tablet, Coated	RETAIL BUSINESS SERVICES , LLC.	OTC MONOGRAPH DRUG
57237-346	Acetaminophen 325 mg/1 Tablet, Film Coated	Rising Pharma Holdings, Inc.	OTC MONOGRAPH DRUG
57237-347	Acetaminophen 500 mg/1 Tablet, Film Coated	Rising Pharma Holdings, Inc.	OTC MONOGRAPH DRUG
57237-304	Acetaminophen 160 mg/5mL Solution	Rising Pharma Holdings, Inc.	OTC MONOGRAPH DRUG
11822-4484	Acetaminophen 500 mg/1 Tablet	Rite Aid Corporation	OTC MONOGRAPH DRUG
0536-1172	Acetaminophen 500 mg/1 Tablet	Rugby Laboratories	OTC MONOGRAPH DRUG
0536-1292	Acetaminophen 500 mg/1 Tablet, Coated	Rugby Laboratories	OTC MONOGRAPH DRUG
0536-1413	Acetaminophen 500 mg/1 Tablet, Film Coated	Rugby Laboratories	OTC MONOGRAPH DRUG
68196-031	Acetaminophen 500 mg/1 Tablet, Film Coated	Sam's West Inc	OTC MONOGRAPH DRUG
68196-177	Acetaminophen 500 mg/1 Tablet	SAM'S WEST INC	OTC MONOGRAPH DRUG
68196-919	Acetaminophen 500 mg/1 Tablet, Coated	Sam's West Inc	OTC MONOGRAPH DRUG
35916-0183	Acetaminophen 500 mg/1 Capsule, Liquid Filled	Softgel Healthcare Pvt Ltd	OTC MONOGRAPH DRUG
69822-692	Acetaminophen 325 mg/1 Tablet	Southern Sales & Service, Inc.	OTC MONOGRAPH DRUG
85766-223	Acetaminophen 500 mg/1 Tablet	Sportpharm LLC	OTC MONOGRAPH DRUG
11673-342	Acetaminophen 500 mg/1 Tablet, Film Coated	TARGET CORPORATION	OTC MONOGRAPH DRUG
11673-167	Acetaminophen 500 mg/1 Tablet	TARGET CORPORATION	OTC MONOGRAPH DRUG
11673-838	Acetaminophen 500 mg/1 Tablet, Coated	TARGET CORPORATION	OTC MONOGRAPH DRUG
49483-341	Acetaminophen 500 mg/1 Tablet, Film Coated	TIME CAP LABS INC	OTC MONOGRAPH DRUG
49483-340	Acetaminophen 325 mg/1 Tablet	TIME CAP LABS INC	OTC MONOGRAPH DRUG
36800-665	Acetaminophen 500 mg/1 Tablet	TOPCO ASSOCIATES LLC	OTC MONOGRAPH DRUG
69396-144	Acetaminophen 500 mg/1 Tablet	Trifecta Pharmaceuticals USA LLC	OTC MONOGRAPH DRUG
69396-140	Acetaminophen 500 mg/1 Tablet	Trifecta Pharmaceuticals USA LLC	OTC MONOGRAPH DRUG
41163-592	Acetaminophen 500 mg/1 Tablet, Coated	UNFI	OTC MONOGRAPH DRUG
87441-008	Acetaminophen 500 mg/1 Tablet	Unit Dose Solutions, Inc.	OTC MONOGRAPH DRUG
41163-500	Acetaminophen 500 mg/1 Tablet, Coated	United Natural Foods, Inc. dba UNFI	OTC MONOGRAPH DRUG
41163-514	Acetaminophen 325 mg/1 Tablet	United Natural Foods, Inc. dba UNFI	OTC MONOGRAPH DRUG
63941-404	Acetaminophen 500 mg/1 Tablet, Coated	VALU MERCHANDISERS COMPANY	OTC MONOGRAPH DRUG
49035-175	Acetaminophen 500 mg/1 Tablet, Film Coated	Wal-Mart Stores Inc	OTC MONOGRAPH DRUG
49035-755	Acetaminophen 500 mg/1 Tablet, Coated	WAL-MART STORES INC	OTC MONOGRAPH DRUG
49035-869	Acetaminophen 500 mg/1 Tablet, Coated	WAL-MART STORES INC	OTC MONOGRAPH DRUG
0363-9798	Acetaminophen 500 mg/1 Tablet	WALGREEN CO.	OTC MONOGRAPH DRUG
0363-9605	Acetaminophen 160 mg/1 Tablet	WALGREEN CO.	OTC MONOGRAPH DRUG
0363-9595	Acetaminophen 500 mg/1 Tablet	WALGREEN CO.	OTC MONOGRAPH DRUG
0363-9810	Acetaminophen 500 mg/1 Tablet	Walgreens	OTC MONOGRAPH DRUG
0363-9538	Acetaminophen 500 mg/1 Tablet	WALGREENS	OTC MONOGRAPH DRUG
79903-269	Acetaminophen 500 mg/1 Tablet	Walmart	OTC MONOGRAPH DRUG
79903-296	Acetaminophen 500 mg/1 Tablet	WALMART INC	OTC MONOGRAPH DRUG
69367-323	Acetaminophen 160 mg/5mL Liquid	Westminster Pharmaceuticals, LLC	OTC MONOGRAPH DRUG
84269-2522	Acetaminophen 500 mg/1 Tablet	Wildman Business Group	OTC MONOGRAPH DRUG
67091-133	Acetaminophen 500 mg/1 Tablet, Coated	WinCo Foods, LLC	OTC MONOGRAPH DRUG
67091-132	Acetaminophen 325 mg/1 Tablet	WinCo Foods, LLC	OTC MONOGRAPH DRUG
17714-012	Acetaminophen 325 mg/1 Tablet	Advance Pharmaceutical Inc.	OTC MONOGRAPH NOT FINAL
71610-238	Acetaminophen 325 mg/1 Tablet	Aphena Pharma Solutions - Tennessee, LLC	OTC MONOGRAPH NOT FINAL
54738-548	Acetaminophen 325 mg/1 Tablet	Richmond Pharmaceuticals, Inc.	OTC MONOGRAPH NOT FINAL
49483-342	Acetaminophen 500 mg/1 Tablet, Film Coated	TIME CAP LABORATORIES, INC	OTC MONOGRAPH NOT FINAL
76168-120	Acetaminophen 500 mg/1 Tablet	Velocity Pharma LLC	OTC MONOGRAPH NOT FINAL

Acetaminophen recalls

D-0596-2025 Sep 3, 2025 · Class II · Ongoing
Discoloration
D-0635-2024 Aug 28, 2024 · Class I · Ongoing
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
D-0631-2024 Aug 14, 2024 · Class I · Terminated
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
D-0566-2024 Jul 3, 2024 · Class II · Ongoing
Discoloration: Brownish tablets
D-1348-2022 Aug 24, 2022 · Class II · Terminated
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
D-0094-2022 Nov 17, 2021 · Class II · Terminated
cGMP Deviations: Product manufactured with contaminated raw ingredient.
D-0095-2022 Nov 17, 2021 · Class II · Terminated
cGMP Deviations: Product manufactured with contaminated raw ingredient.
D-0358-2021 May 12, 2021 · Class I · Terminated
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
D-0248-2021 Feb 10, 2021 · Class II · Terminated
Discoloration and failed pH specifications
D-0858-2020 Feb 19, 2020 · Class II · Terminated
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.

Frequently asked questions

What is Acetaminophen used for?

Who makes Acetaminophen?

Acetaminophen is listed by 133 labelers in the FDA NDC directory, including A-S Medication Solutions, American Health Packaging, Asclemed USA, Inc., Aurohealth LLC.

Has Acetaminophen been recalled?

The FDA enforcement database lists 10 recalls for Acetaminophen, most recently D-0596-2025 (class ii): Discoloration