Acetaminophen is a medicine sold in the U.S. under 6 brand and generic names, for fever and pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Acetaminophen (application NDA204767). Other acetaminophen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. ( 2.4 ) 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 ) 2.1 General Dosing Information Acetaminophen Injection, for intravenous use, 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 and 2 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total…
The following serious adverse reactions are discussed elsewhere in the labeling: Hepatic Injury [see Warnings and Precautions ( 5.1 )] Serious Skin Reactions [see Warnings and Precautions ( 5.2 )] Allergy and Hypersensitivity [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in patients treated with acetaminophen were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551- 7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Adult Population A total of 1,020 adult patients have received acetaminophen in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17% (n=173) who received more than 10 doses. Most patients were treated with acetaminophen 1,000 mg every 6 hours. A total of 13.1% (n=134) received acetaminophen 650 mg every 4 hours. All adverse reactions that occurred in adult patients treated with either acetaminophen or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Over-the-counter | Suppository | Generic | $0 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AI;II | 250 mg / 125 mg | yellow | capsule | — |
| T;II | 250 mg / 125 mg | yellow | oval | — |
| T;24 | 50 mg / 325 mg / 40 mg | blue | round | — |
| A30 | 50 mg / 325 mg / 40 mg | white | capsule | — |
| I;I | 250 mg / 125 mg | yellow | oval | — |
| FIORICET;CODEINE |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Dec 16, 2025
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Dec 16, 2025
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by:…
Defective Container
Kenvue Brands LLC · Oct 21, 2025
Acetaminophen 500mg Caffeine 65mg caplets
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Aero Healthcare · Oct 17, 2025
Acetaminophen Injection 1000 mg/100 mL (10 mg/mL)
Discoloration
Baxter Healthcare Corporation · Aug 20, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Acetaminophen is contraindicated: in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. in patients with severe hepatic impairment or severe active liver disease [see Warnings and Precautions ( 5.1 )]. Acetaminophen is contraindicated: In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation. ( 4 ) In patients with severe hepatic impairment or severe active liver disease. ( 4 )
Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. ( 7.1 ) Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. ( 7.2 ) 7.1 Effects of Other Substances on Acetaminophen Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. The clinical consequences of these effects have not been established. Effects of ethanol are complex, because excessive alcohol usage can induce hepatic cytochromes, but ethanol also acts as a competitive inhibitor of the metabolism of acetaminophen. 7.2 Anticoagulants Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short-term use of acetaminophen in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.
| 62/100 |
| Prescription |
| Capsule |
| Generic |
| $0 |
| View → |
| 3 | Not yet rated | Prescription | Suppository | Generic | $0 | View → |
| 4 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |
| 5 | Not yet rated | Prescription | Suppository | Generic | $0 | View → |
| 6 | Not yet rated | Over-the-counter | Tablet | Generic | $0 | View → |
| 50 mg / 300 mg / 40 mg / 30 mg |
| gray, blue |
| capsule |
| — |
| WATSON;3220 | 30 mg / 50 mg / 40 mg / 325 mg | blue, white | capsule | — |
|---|
| EO;XA;5;325 | 5 mg / 325 mg | white | capsule | — |
|---|
| B073 | 50 mg / 325 mg / 40 mg / 30 mg | blue, gray | capsule | — |
|---|
| EO;XA;7;5;325 | 7.5 mg / 325 mg | white | capsule | — |
|---|
| EO;XA;10;325 | 10 mg / 325 mg | white | capsule | — |
|---|
| EO;XA;7;5;325 | 7.5 mg / 325 mg | white | capsule | — |
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