Advil Dual Action With Acetaminophen
bd0d7812-4e42-b533-e053-2995a90ae1f9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
Warnings
Indications and Usage
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- muscular aches
- minor pain of arthritis
Dosage and Administration
Directions
- do not take more than directed
| adults and children 12 years and over |
|
| children under 12 years |
|
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
Description
Drug Facts
Section 42229-5
Drug Facts
Section 44425-7
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)
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 51727-6
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide
Section 53413-1
Questions or comments?
call weekdays 9 AM to 5 PM at 1-800-88-ADVIL
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Section 55105-1
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Ibuprofen 125 mg (NSAID
nonsteroidal anti-inflammatory drug )
|
Pain reliever |
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
Principal Display Panel
When Using This Product
- take with food or milk if stomach upset occurs
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
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
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.
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
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
Structured Label Content
Indications and Usage (34067-9)
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- muscular aches
- minor pain of arthritis
Dosage and Administration (34068-7)
Directions
- do not take more than directed
| adults and children 12 years and over |
|
| children under 12 years |
|
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
Warnings and Precautions (34071-1)
Warnings
Section 42229-5 (42229-5)
Drug Facts
Section 44425-7 (44425-7)
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)
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 51727-6 (51727-6)
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ferric oxides, glyceryl dibehenate, hypromellose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, titanium dioxide
Section 53413-1 (53413-1)
Questions or comments?
call weekdays 9 AM to 5 PM at 1-800-88-ADVIL
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Section 55105-1 (55105-1)
| Active ingredients (in each caplet) | Purposes |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Ibuprofen 125 mg (NSAID
nonsteroidal anti-inflammatory drug )
|
Pain reliever |
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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
When Using This Product (When using this product)
- take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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
Nsaid Stomach Bleeding Warning (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 (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.
Acetaminophen Liver Damage Warning (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
Ask A Doctor Or Pharmacist Before Use If You Are (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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:02:58.183587 · Updated: 2026-03-14T23:02:48.423363