Is Acetaminophen a prescription drug?

No. Acetaminophen is sold over the counter (OTC) without a prescription.

Are there other products with the same active ingredient as Acetaminophen?

Yes. Other FDA-listed products with the same active ingredients include Acetaminophen and Ibuprofen, dual action, Acetaminophen and Ibuprofen (Nsaid), dual action pain reliever.

Who makes Acetaminophen?

81 manufacturers list Acetaminophen with the FDA, including Walgreens, AAA Pharmaceutical, Inc., AARNA USA INC.

Checked Oct 26, 2026

OTC

Acetaminophen

Acetaminophen is a nonsteroidal anti-inflammatory drug (over-the-counter), made by 81 manufacturers.

Type: Over the counter
Drug class: Nonsteroidal Anti-inflammatory Drug
Route: Oral
Manufacturers: 81; + 44 repackager labels

■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever

Drug facts

Name: Acetaminophen
Active ingredients: Acetaminophen, Ibuprofen
Drug class: Nonsteroidal Anti-inflammatory Drug
How it works: Cyclooxygenase Inhibitors
Dosage forms: Capsule, liquid filled, Liquid, Solution, Suspension, Syrup, Tablet, Tablet, coated, Tablet, extended release, Tablet, film coated, Tablet, film coated, extended release
Label holder: Walgreens
FDA application: M013
Label updated: 08/24/2026

Active ingredients

Acetaminophen 500mg Pain reliever/fever reducer

Purpose

Pain reliever/ Fever reducer

Uses

Temporarily relieves minor aches and pains due to:
Headache
Muscular aches
Backache
Minor pain of arthritis
The common cold
Toothache
Premenstrual and menstrual cramps
Temporarily reduces fever

Directions

Do not take more than directed (see overdose warning) adults and children 12 years and over
Take 2 gelcaps every 6 hours while symptoms last
Do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
Do not use for more than 10 days unless directed by a doctor children under 12 years
Ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

More than 4,000 mg of acetaminophen in 24 hours
With other drugs containing acetaminophen
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.

Do not use

With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
If you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor

Stop use and ask a doctor if

Pain gets worse or lasts more than 10 days
Fever gets worse or lasts more than 3 days
New symptoms occur
Redness or swelling is present These could be signs of a serious condition.

Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

Keep out of the reach of children

Overdose

Overdose warning In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information

Store at 20°-25°C (68°-77°F).
Avoid high humidity
See end panel for expiration date and lot number (carton)
See bottom of label for expiration date and lot number (label)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxy propyl cellulose, hydroxy propyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, stearic acid, titanium dioxide

Questions?

And comments? call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Forms and strengths

From the FDA NDC Directory · 189 product codes

Dosage form	Strength	Route	NDCs
Capsule, liquid filled	500 mg	oral	1
Liquid	160 mg/5mL	oral	4
Solution	160 mg/5mL	oral	5
Solution	325 mg/10.15mL	oral	4
Solution	650 mg/20.3mL	oral	5
Solution	1000 mg/30mL	oral	2
Suspension	160 mg/5mL	oral	10
Suspension	325 mg/10.15mL	oral	1
Suspension	650 mg/20.3mL	oral	1
Syrup	500 mg/15mL	oral	1
Tablet	.5 g/g	oral	1
Tablet	160 mg	oral	2
Tablet	250 mg / 125 mg	oral	1
Tablet	325 mg	oral	17
Tablet	500 mg	oral	62
Tablet	650 mg	oral	11
Tablet, coated	325 mg	oral	1
Tablet, coated	500 mg	oral	18
Tablet, extended release	650 mg	oral	18
Tablet, film coated	325 mg	oral	4
Tablet, film coated	500 mg	oral	9
Tablet, film coated, extended release	650 mg	oral	11

What pharmacies pay

National Average Drug Acquisition Cost (NADAC), week of 10/21/2026

All prices

NADAC lists 31 package codes for this drug, priced in different units.

NADAC is a survey of what retail pharmacies pay to buy a drug. It is not the price you pay at the counter, which depends on your insurance and the pharmacy.

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 445,036 reports that list acetaminophen, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

Drug ineffective37,633
Fatigue36,342
Off label use34,857
Nausea31,499
Headache30,238
Pain29,611
Diarrhea25,002
Dyspnea24,049
Arthralgia23,147
Vomiting22,036

To report a side effect, use FDA MedWatch.

Manufacturers and labels

178 FDA labels · 44 from repackagers

WalgreensShown hereM013 · Label 08/24/2026 · NDC 0363-9810Full label
AAA Pharmaceutical, Inc.M013 · Label 12/02/2024 · NDC 57344-004Full label
AARNA USA INC.M013 · Label 05/01/2025 · NDC 82568-0002Full label
AARNA USA INC.M013 · Label 04/29/2025 · NDC 82568-0001Full label
AMERIFOODS TRADING COMPANYM013 · Label 10/31/2023 · NDC 61504-104Full label
ARMY AND AIR FORCE EXCHANGE SERVICEM013 · Label 04/02/2026 · NDC 55301-175Full label
Acetris Pharma Holdings, LLCM013.50 · Label 05/13/2026 · NDC 52343-555Full label
Advance Pharmaceutical Inc.part343 · Label 12/22/2017 · NDC 17714-012Full label
Akron Pharma Inc.M013 · Label 08/24/2026 · NDC 71399-1026Full label
Akron Pharma Inc.M013 · Label 04/10/2026 · NDC 71399-1025Full label
American Health PackagingM013 · Label 10/21/2024 · NDC 60687-740Full label
American Health PackagingM013 · Label 10/21/2024 · NDC 60687-751Full label
Aurohealth LLCANDA207229 · Label 05/21/2026 · NDC 58602-848Full label
Aurohealth LLCANDA207229 · Label 01/24/2024 · NDC 58602-730Full label
Aurohealth LLCANDA207229 · Label 01/24/2024 · NDC 58602-873Full label
Aurohealth LLCM013 · Label 11/29/2023 · NDC 58602-773Full label
Aurohealth LLCM013 · Label 11/29/2023 · NDC 58602-774Full label
BETTER LIVING BRANDS LLC.M013 · Label 12/18/2025 · NDC 21130-353Full label
BETTER LIVING BRANDS LLC.M013 · Label 12/18/2025 · NDC 21130-356Full label
Better Living Brands, LLCANDA207229 · Label 04/21/2026 · NDC 21130-108Full label
BluePoint LaboratoriesANDA207229 · Label 06/05/2024 · NDC 68001-495Full label
CHAIN DRUG MARKETING ASSOCIATION INCANDA211544 · Label 12/10/2025 · NDC 63868-660Full label
CHAIN DRUG MARKETING ASSOCIATION INCM013 · Label 12/26/2024 · NDC 63868-677Full label
CHAIN DRUG MARKETING ASSOCIATION INCM013 · Label 12/26/2024 · NDC 63868-678Full label
CHAIN DRUG MARKETING ASSOCIATION INC.M013 · Label 12/26/2024 · NDC 63868-809Full label
COSTCO WHOLESALE CORPORATIONM013 · Label 06/03/2026 · NDC 63981-019Full label
CVS HEALTH CORPM013 · Label 02/13/2025 · NDC 69842-968Full label
CVS PHARMACYM013 · Label 07/29/2026 · NDC 69842-445Full label
CVS PHARMACY INCANDA211544 · Label 12/23/2025 · NDC 69842-322Full label
CVS PHARMACY iNCANDA211544 · Label 12/19/2025 · NDC 69842-297Full label

Repackager labels (44)

A-S Medication Solutions04/24/2025
A-S Medication Solutions04/24/2025
A-S Medication Solutions04/24/2025
A-S Medication Solutions11/17/2023
ASCLEMED USA INC.06/04/2026
American Health Packaging02/04/2026
Aphena Pharma Solutions - Tennessee, LLC02/26/2019
Bryant Ranch Prepack05/08/2026
Bryant Ranch Prepack10/02/2025
Bryant Ranch Prepack11/01/2024
Bryant Ranch Prepack11/01/2024
Bryant Ranch Prepack10/07/2024
Bryant Ranch Prepack05/30/2024
Bryant Ranch Prepack05/29/2024
Cardinal Health 107, LLC04/22/2026
Cardinal Health 107, LLC04/13/2026
Cardinal Health 107, LLC04/07/2026
HF Acquisition Co LLC, DBA HealthFirst01/15/2026
HF Acquisition Co LLC, DBA HealthFirst05/16/2025
Major Pharmaceuticals01/09/2025
NCS HealthCare of KY, LLC dba Vangard Labs02/26/2026
NCS HealthCare of KY, LLC dba Vangard Labs02/26/2026
NCS HealthCare of KY, LLC dba Vangard Labs02/26/2026
NCS HealthCare of KY, LLC dba Vangard Labs02/26/2026
NCS HealthCare of KY, LLC dba Vangard Labs08/19/2024
NuCare Pharmaceuticals, Inc.06/11/2026
NuCare Pharmaceuticals, Inc.01/27/2026
NuCare Pharmaceuticals,Inc.07/24/2026
NuCare Pharmaceuticals,Inc.10/03/2025
NuCare Pharmaceuticals,Inc.06/14/2024
PD-Rx Pharmaceuticals, Inc.01/12/2026
PD-Rx Pharmaceuticals, Inc.10/08/2025
PD-Rx Pharmaceuticals, Inc.02/17/2025
Precision Dose, Inc.08/29/2025
Precision Dose, Inc.02/19/2025
Precision Dose, Inc.02/19/2025
Precision Dose, Inc.12/04/2024
Preferred Pharmaceuticals Inc.06/11/2026
Preferred Pharmaceuticals Inc.04/15/2026
Preferrred Pharmaceuticals Inc.04/15/2026
Proficient Rx LP04/01/2025
Proficient Rx LP12/01/2023
Sportpharm LLC06/25/2026
Unit Dose Solutions, Inc.06/04/2026

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Acetaminophen: common questions

What is Acetaminophen used for?: ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever
Is Acetaminophen a prescription drug?: No. Acetaminophen is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Acetaminophen?: Yes. Other FDA-listed products with the same active ingredients include Acetaminophen and Ibuprofen, dual action, Acetaminophen and Ibuprofen (Nsaid), dual action pain reliever.
Who makes Acetaminophen?: 81 manufacturers list Acetaminophen with the FDA, including Walgreens, AAA Pharmaceutical, Inc., AARNA USA INC.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 08/24/2026 · Label text is shown as published by the manufacturer. Not medical advice