Dual Action

Manufacturer
CVS | Granules Consumer Health, LLC
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:39

Label at a glance#

ProductAcetaminophen and Ibuprofen
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure17 sections

Indications and uses

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

Dosage and administration

■ 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

Storage and handling

■ read all warnings and directions before use. Keep carton. ■ store at 20 to 25°C (68 to 77°F) ■ avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

■ 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

OTC - ASK DOCTOR SECTION

■ 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

OTC - ASK DOCTOR/PHARMACIST SECTION

■ 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

OTC - WHEN USING SECTION

■ take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

■ 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

Other information

STORAGE AND HANDLING SECTION

■ read all warnings and directions before use. Keep carton.
■ store at 20 to 25°C (68 to 77°F)
■ avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 or comments?

OTC - QUESTIONS SECTION

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

Principal Drug Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Drug Panel - CartonPrincipal Drug Panel - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Drug Panel - LabelPrincipal Drug Panel - Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-40151316-401-81, 51316-401-72

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5593b450-e2a9-f0ec-e063-6294a90ae9e62f3a6c80-0b84-c469-e063-6394a90aea8e2025-07-01WarningsExact identifier
spl id: 5593b450-e2a9-f0ec-e063-6294a90ae9e6
spl set id: 2f3a6c80-0b84-c469-e063-6394a90aea8e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.