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OTC products · Product label record

dual pain reliever drug information

ACETAMINOPHEN, IBUPROFEN
Walgreen Company · ORAL

Product NDC: 0363-5220

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN, IBUPROFEN
Labeler / manufacturerWalgreen Company
RouteORAL
Drug classNonsteroidal Anti-inflammatory Drug
Product NDC0363-5220
Label effective date2026-08-26

Official product label reference

dual pain reliever — Walgreen Company

This page contains 15 source sections for ACETAMINOPHEN, IBUPROFEN, oral route. Label set 5cb3b0b4-5b47-4ed4-a5e3-f14dbbcb46df, version 5.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purposes Pain reliever
Dosage and administration — label text
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
Warnings
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.
Active ingredient
Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Do not use
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
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
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
While using this medicine
When using this product • take with food or milk if stomach upset occurs
When to stop use and seek help
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
Pregnancy or breast feeding
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.
Child safety
Keep out of reach of children.
Storage and handling
Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)
Inactive ingredient
Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
Questions
Questions or comments? 1-800-719-9260

Official sources and product identifiers

Substances listed: ACETAMINOPHEN, IBUPROFEN

RxNorm identifiers: 2387532

Package NDC codes

0363-5220-68, 0363-5220-23, 0363-5220-16, 0363-5220-01

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.