Acetaminophen: uses, dosing, side effects & brands
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.
Key facts
- Treats (across its forms)
- Fever and Pain
- Available as
- Suppository · Tablet, extended release · Injectable · Suspension · Tablet
- Sold as
- 6 products — Acephen, Infants' Feverall and Tylenol, and others
- Prescription?
- Both Rx and OTC forms
- Generic available?
- Yes
- What the pharmacy pays
- about $0.03 per ml — not your price
- Boxed warning
- Boxed warning
How Acetaminophen is dosed
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…
Everything below is the FDA label for Acetaminophen (injectable, suspension, tablet, tablet, extended release). Acetaminophen is also sold as suppository, and those are different medicines to take — follow the label for the one you were prescribed.
Acetaminophen side effects
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 ≥…
Who shouldn’t take Acetaminophen
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 )
Acetaminophen drug interactions
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.
Can you take acetaminophen with…?
Source-cited answers for the combinations people actually ask about — each with a verdict and what to watch for.
Every acetaminophen product we track (6)
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? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Suppository | Generic | $0 | View → | |
| 2 | 70/100 | Over-the-counter | Suppository | Generic | $0 | View → | |
| 3 | 70/100 | Over-the-counter | Tablet | Generic | $0 | View → | |
| 4 | 68/100 | Prescription | Injectable | Generic | $0 | View → | |
| 5 | Not yet rated | Prescription | Injectable | Generic | $0 | View → | |
| 6 | Not yet rated | Prescription | Suppository | Generic | $0 | View → |
What acetaminophen pills look like
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 |
|---|---|---|---|---|
| 44;148 | 500 mg | white | round | — |
| HH6 | 65 mg / 250 mg | white | capsule | — |
| A | 80 mg | red | round | — |
| S99 | 325 mg | white | round | — |
| cor116 | 650 mg | white | oval | — |
| H325 | 325 mg | white | round | — |
| G1;G3 | 500 mg / 25 mg | gray, gray | oval | — |
| HTP500 | 500 mg | white | capsule | — |
| G1 | 500 mg | gray | oval | — |
| TYLENOL;500 | 500 mg | white | oval | — |
| 54;27 | 500 mg | white | round | — |
| G650 | 650 mg | white | capsule | — |
Combination products containing acetaminophen
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.
Acetaminophen recalls
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
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
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Aurobindo Pharma USA Inc · May 22, 2025
Can you crush or split acetaminophen?
At least one acetaminophenproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each acetaminophen label says about crushing, splitting and chewingHow long acetaminophen keeps
No acetaminophen label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does acetaminophen expire? The in-use limits and storage rules from its labelsGiving acetaminophen to a child
Children’s acetaminophen is sold at 18 different strengths, and each has its own dosing chart on its label — a chart is only correct for the bottle it was printed on. We hold the chart from 74 labelled products.
Children’s acetaminophen dosage charts, by strengthAcetaminophen and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for acetaminophen: levels in milk, effects in breastfed infants, and the drugs it would consider insteadAcetaminophen is a good choice for analgesia, and fever reduction in nursing mothers. Giving acetaminophen and ibuprofen on a fixed schedule for 24 hours after vaginal delivery appears to increase the breastfeeding rate. There is no difference in breastfeeding initiation rate between ibuprofen or acetaminophen alone after vaginal delivery. Amounts in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare.
National Institute of Child Health and Human Development, record revised April 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about acetaminophen
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 487,900 reports naming acetaminophen, and the FDA flagged 86% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue28,521 reports
- nausea26,807 reports
- headache23,393 reports
- dyspnoea20,164 reports
- vomiting20,063 reports
- diarrhoea19,783 reports
- emotional distress19,078 reports
- arthralgia18,740 reports
Read these as a signal, not a rate. A report does not mean acetaminophen caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Can you drink alcohol on acetaminophen?
The label says use caution
The label's Liver warning addresses alcohol: it states that severe liver damage may occur if you take this acetaminophen product together with 3 or more alcoholic drinks every day while using it (or if you exceed the maximum daily amount, or take it with other acetaminophen-containing drugs). The concern is additive liver toxicity from combining acetaminophen with heavy alcohol use, not a disulfiram-like reaction.
Is acetaminophen safe during pregnancy?
The label reports no clear risk
The label's §8.1 Pregnancy Risk Summary states that published epidemiological studies of oral acetaminophen use during pregnancy have not reported a clear association with birth defects, miscarriage, or adverse maternal or fetal outcomes. It cites large studies (e.g., over 26,000 first-trimester-exposed pregnancies and a National Birth Defects Prevention case-control study) that found no increased risk of congenital malformations, but notes these studies cannot definitively establish the absence of any risk due to methodological limitations. It also notes that animal reproduction/developmental studies identified adverse effects (fetotoxicity, bone variations, reduced offspring birth weight, effects on fertility) at doses around the maximum human daily dose. The estimated background risk of birth defects and miscarriage in the general population is given as 2-4% and 15-20% respectively. Anyone who is pregnant should discuss use with their prescriber rather than starting or stopping on their own.
This is what acetaminophen’s FDA label says — not a recommendation to take or stop it. In pregnancy, that decision is your prescriber’s; do not start or stop a medicine on your own.
Acetaminophen injection — DailyMed FDA label (§8.1 Pregnancy) ↗Related guides
Related calculators
Frequently asked questions
What is Acetaminophen?
Acetaminophen is a medication used to treat Fever, Pain.
Is acetaminophen safe during pregnancy?
The label's §8.1 Pregnancy Risk Summary states that published epidemiological studies of oral acetaminophen use during pregnancy have not reported a clear association with birth defects, miscarriage, or adverse maternal or fetal outcomes. It cites large studies (e.g., over 26,000 first-trimester-exposed pregnancies and a National Birth Defects Prevention case-control study) that found no increased risk of congenital malformations, but notes these studies cannot definitively establish the absence of any risk due to methodological limitations. It also notes that animal reproduction/developmental studies identified adverse effects (fetotoxicity, bone variations, reduced offspring birth weight, effects on fertility) at doses around the maximum human daily dose. The estimated background risk of birth defects and miscarriage in the general population is given as 2-4% and 15-20% respectively. Anyone who is pregnant should discuss use with their prescriber rather than starting or stopping on their own. This is what acetaminophen's FDA label says; whether to use it in pregnancy is your prescriber's decision.
Can you drink alcohol while taking acetaminophen?
The label's Liver warning addresses alcohol: it states that severe liver damage may occur if you take this acetaminophen product together with 3 or more alcoholic drinks every day while using it (or if you exceed the maximum daily amount, or take it with other acetaminophen-containing drugs). The concern is additive liver toxicity from combining acetaminophen with heavy alcohol use, not a disulfiram-like reaction. This is what acetaminophen's FDA label says; alcohol advice depends on your dose and health, so confirm with your pharmacist.
Can you take acetaminophen with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run acetaminophen against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is acetaminophen sold under?
We track 6 acetaminophen-containing products in the U.S.: Acephen, Infants' Feverall, Tylenol, Acetaminophen, Injectapap and Neopap. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does acetaminophen come in?
Across the brands we track, acetaminophen is currently marketed as suppository, tablet, extended release, injectable, suspension and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic acetaminophen?
Yes. Our catalog lists 1 generic acetaminophen product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has acetaminophen been recalled?
The FDA's Enforcement database lists at least 5 recall records whose product description mentions acetaminophen. The most recent: Oxycodone and Acetaminophen CII Tablets USP (Dec 16, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
What should I avoid while taking acetaminophen?
Alcohol: the FDA label flags alcohol as something to be careful with — see the alcohol section above for what it actually says. Other medicines: we hold source-cited interaction answers for Can you take ibuprofen and Tylenol together?, Can you take naproxen with Tylenol?, Can you take Benadryl with Tylenol? and Can you take Aleve with Tylenol? and more. This is what the FDA label and our cited sources say — it is not a complete list. Your pharmacist can check your own combination.
Cite this page
- APA
- pharmaranks. (2026, July 24). Acetaminophen: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/acetaminophen
- MLA
- “Acetaminophen: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/acetaminophen.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for acetaminophen on DailyMed (NIH) ↗ — including its boxed warning in full.