Drug Facts
acaa9806-e552-44f2-a680-b8bb64c49e1f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever Pain reliever
Medication Information
Warnings and Precautions
Warnings
Indications and Usage
Uses
-
•temporarily relieves minor aches and pains due to:
-
•backache
-
•muscular aches
-
•minor pain of arthritis
-
•headache
-
•toothache
-
•menstrual cramps
-
Purpose
Pain reliever Pain reliever
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
Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Section 42229-5
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.
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 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
Purposes
Pain reliever
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
NEW
Advil
DUAL ACTION
WITH Acetaminophen
BACK PAIN
Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
8 HOUR RELIEF
144
Caplets*
*Capsule-Shaped Tablets
000065288 Front Carton
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
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.
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
Active Ingredients (in Each Caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
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:
-
•backache
-
•muscular aches
-
•minor pain of arthritis
-
•headache
-
•toothache
-
•menstrual cramps
-
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)
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.
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 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
Purposes
Pain reliever
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)
NEW
Advil
DUAL ACTION
WITH Acetaminophen
BACK PAIN
Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
8 HOUR RELIEF
144
Caplets*
*Capsule-Shaped Tablets
000065288 Front Carton
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
If Pregnant 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.
Keep Out of Reach of Children. (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.
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
Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
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: 2026-02-15T12:03:00.785594 · Updated: 2026-03-14T23:02:50.389879