Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Over-the-counter medicine · no prescription needed

Acetaminophen and ibuprofen

Purpose on the label: Pain reliever Pain reliever

Pain and fever

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Acetaminophen and ibuprofen used for?
The Drug Facts label of Advil Dual Action with Acetaminophen (Haleon US Holdings LLC) lists these uses: temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis.
Do I need a prescription for Acetaminophen and ibuprofen?
No, the products on this page are sold without a prescription. Other products with the same active ingredients need a prescription (often a higher strength or another form): see the prescription page.
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Acetaminophen and ibuprofen been recalled?
FDA enforcement reports list 1 recall of products on this page; the newest started March 13, 2025. A recall usually concerns specific products or lots, not every brand.

Also sold by prescription (often at a higher strength or in another form): Acetaminophen and ibuprofen — prescription medicine

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Advil Dual Action with Acetaminophen · Haleon US Holdings LLC

Acetaminophen 250 mg · Ibuprofen 125 mg, tablet, film coated (oral)

Active ingredient (in each caplet)

Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever

Uses

  • temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis

Warnings

  • Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • with other drugs containing acetaminophen
  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • 3 or more alcoholic drinks every day while using this product
  • Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash If skin reaction occurs, stop use and seek medical help right away.
  • NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 have ever had an allergic reaction to acetaminophen or any other pain reliever
  • right before or after heart surgery

Ask a doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if

you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get better
  • you have symptoms of heart problems or stroke: o chest pain o trouble breathing o weakness in one part or side of body o slurred speech o leg swelling
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed

adults and children 12 years and over
  • • take 2 caplets every 8 hours while symptoms persist
children under 12 years
  • • ask a doctor
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide

Questions?

call weekdays 9 AM to 5 PM at 1-800-88-ADVIL

— FDA label of Advil Dual Action with Acetaminophen, Haleon US Holdings LLC, effective April 21, 2025. See the official label on DailyMed →

Acetaminophen and Ibuprofen (NSAID) · Rite Aid

Acetaminophen 250 mg · Ibuprofen 125 mg, tablet (oral)

Active ingredient (in each caplet)

Acetaminophen 250 mg Ibuprofen 125 mg (NSAID**) **nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • muscular aches
  • minor pain of arthritis

Warnings

  • Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • with other drugs containing acetaminophen
  • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • 3 or more alcoholic drinks every day while using this product
  • Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • blisters
  • rash If skin reaction occurs, stop use and seek medical help right away.
  • NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed
  • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 have ever had an allergic reaction to acetaminophen or any other pain reliever
  • right before or after heart surgery

Ask a doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if

you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • Take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed adults and children 12 years and over
  • take 2 caplets every 8 hours while symptoms persist children under 12 years
  • ask a doctor
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.

Questions?

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

— FDA label of Acetaminophen and Ibuprofen (NSAID), Rite Aid, effective December 19, 2025. See the official label on DailyMed →

Dual Action Pain Relief · Allegiant Health

Acetaminophen 250 mg · Ibuprofen 125 mg, capsule (oral)

Active ingredient (s)

Acetaminophen 250 mg Ibuprofen 125 mg (NSAID**) **nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever

Uses

(s) temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis

Warnings

  • Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen more than 6 caplets in 24 hours, which is the maximum daily amount for this product 3 or more alcoholic drinks every day while using this product
  • Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If skin reaction occurs, stop use and seek medical help right away.
  • NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away.
  • NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed
  • Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 have ever had an allergic reaction to acetaminophen or any other pain reliever
  • right before or after heart surgery

Ask a doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breastfeeding

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed adults and children 12 years and over: take 2 caplets every 8 hours while symptoms persist children under 12 years: ask a doctor do not take more than 6 caplets in 24 hours, unless directed by a doctor

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.

Questions?

/Comments Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

— FDA label of Dual Action Pain Relief, Allegiant Health, effective March 29, 2024. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Acetaminophen 250 mg · Ibuprofen 125 mg · tablet, film coated (oral) · 52 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Advil Dual Action with Acetaminophen Haleon US Holdings LLC DailyMed
Advil Dual Action with Acetaminophen Lil' Drug Store Products, Inc. DailyMed
Advil Dual Action with Acetaminophen Navajo Manufacturing Company Inc. DailyMed
Advil Dual Action with Acetaminophen Select Consumer Group DailyMed
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain Haleon US Holdings LLC DailyMed
Advil Dual Action with Acetaminophen, Travel BASIX Lil' Drug Store Products, Inc. DailyMed
Acetaminophen 250 mg and Ibuprofen 125 mg Dr. Reddy's Labortories Inc DailyMed
Acetaminophen 250 mg and Ibuprofen 125 mg Marksans Pharma Limited DailyMed
Acetaminophen 250 mg and Ibuprofen 125 mg R J General Corporation DailyMed
Acetaminophen and Ibuprofen Amerisource Bergen DailyMed
Acetaminophen and Ibuprofen Aurohealth LLC DailyMed
Acetaminophen and Ibuprofen Bionpharma Inc. DailyMed
Acetaminophen and Ibuprofen CVS Pharmacy DailyMed
Acetaminophen and Ibuprofen Discount Drug Mart, Inc. DailyMed
Acetaminophen and Ibuprofen Kroger Company DailyMed
Acetaminophen and Ibuprofen L.N.K. International, Inc. —
Acetaminophen and Ibuprofen Meijer Distribution Inc DailyMed
Acetaminophen and Ibuprofen Walgreen Company DailyMed
Acetaminophen and Ibuprofen Back Pain Aurohealth LLC DailyMed
Acetaminophen, Ibuprofen Glenmark Therapeutics Inc., USA DailyMed
Basic Care Dual Action Amazon.com Services LLC DailyMed
Careone Dual Action Retail Business Services, LLC DailyMed
Dg Health Dual Back Pain Reliever Dolgencorp Inc DailyMed
DG health dual pain reliever Dolgencorp Inc DailyMed
Dual Action Amazon.com Services LLC DailyMed

Showing 25 of 48 brands.

Acetaminophen 250 mg · Ibuprofen 125 mg · tablet (oral) · 20 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Aacetaminophen and Ibuprofen Granules USA, Inc. DailyMed
Acetaminophen Raonbio Corp DailyMed
Acetaminophen 250 mg and Ibuprofen 125 mg Sun Pharmaceutical Industries, Inc. DailyMed
Acetaminophen and Ibuprofen Cvs DailyMed
Acetaminophen and Ibuprofen Family Dollar DailyMed
Acetaminophen and Ibuprofen Granules Pharmaceuticals Inc. —
Acetaminophen and Ibuprofen LEADER/ Cardinal Health 110, Inc. DailyMed
Acetaminophen and Ibuprofen Rugby Laboratories DailyMed
Acetaminophen and Ibuprofen Wal-Mart Stores Inc. DailyMed
Acetaminophen and Ibuprofen Walgreens DailyMed
Acetaminophen and Ibuprofen (NSAID) Retail Business Services, LLC DailyMed
Acetaminophen and Ibuprofen (NSAID) Rite Aid DailyMed
Acetaminophen and Ibuprofen (NSAID) Wal-Mart Stores Inc. DailyMed
Acetaminophen and Ibuprofen Back Pain Granules Pharmaceuticals Inc. —
Dual Action Better Living Brands, LLC DailyMed
Dual Action Kroger Company DailyMed
Dual Action Pain Relief Target Corporation DailyMed
Dual Action Pain Relief Time Cap Laboratories, Inc. DailyMed
Period Pills by Biikay Kai Squared DailyMed
Acetaminophen 250 mg · Ibuprofen 125 mg · capsule (oral) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Dual Action Pain Relief Allegiant Health DailyMed

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Acetaminophen and ibuprofen, by strength and form
Strength and formGeneric or brandPharmacies pay
acetaminophen 250 mg · ibuprofen 125 mg
tablet
Generic $0.0934 per tablet
acetaminophen 250 mg · ibuprofen 125 mg
tablet, film coated
Generic $0.0934 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • Bionpharma Inc.4 products
  • Walgreen Company3 products
  • Walmart Inc.3 products
  • Amazon.com Services LLC2 products
  • Retail Business Services, LLC2 products
  • Topco Associates LLC2 products
  • Meijer, Inc.2 products
  • Haleon US Holdings LLC2 products
  • Amerisource Bergen2 products
  • Dolgencorp Inc2 products
  • Kroger Company2 products
  • Cvs2 products
  • Lil' Drug Store Products, Inc.2 products
  • CVS Pharmacy2 products
  • Granules Pharmaceuticals Inc.2 products
  • L. Perrigo Company2 products
  • Chain Drug Marketing Association Inc.2 products
  • Wal-Mart Stores Inc.2 products
  • Aurohealth LLC2 products
  • Rugby Laboratories1 product
  • Dr. Reddy's Labortories Inc1 product
  • Sun Pharmaceutical Industries, Inc.1 product
  • Granules USA, Inc.1 product
  • R J General Corporation1 product
  • Rite Aid Corporation1 product
  • LEADER/ Cardinal Health 110, Inc.1 product
  • Dr. Reddy's Laboratories Inc1 product
  • Sportpharm LLC1 product
  • L.N.K. International, Inc.1 product
  • Allegiant Health1 product

Showing the 30 companies with the most products, of 50.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

  1. March 13, 2025 · Class II · Ongoing · D-0347-2025

    CGMP Deviations

    Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of Ind — Glenmark Pharmaceuticals Inc., USA

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

Report an error → · Information for medicine makers