Advil

Advil
SPL v2
SPL
SPL Set ID 68d3be55-9340-4cc9-a05a-12b9338ddc56
Route
ORAL
Published
Effective Date 2024-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Ibuprofen (125 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Ferric Oxide Red Glyceryl Dibehenate Hypromellose, Unspecified Polydextrose Polyethylene Glycol, Unspecified Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Advil;II Shape: oval Color: yellow Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-30

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • muscular aches
    • minor pain of arthritis
Section 42229-5

Drug Facts

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.

Directions
  • do not take more than directed
adults and children 12 years and over    •  take 2 caplets every 8 hourswhile symptoms persist
children under 12 years  • ask a doctor
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
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
Other Information
  • read all warnings and directions before use.
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients

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

Questions Or Comments?

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

Distributed by:

GSK CH, Warren,

NJ 07059

Packaged and distributed by RJ Corp with the permission of HALEON.

Principal Display Panel

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets - NDC 70264-040-12 -  50 Caplets Carton Label

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.

Active Ingredients (in Each Caplet)
Active ingredients (in each tablet) Purpose
Acetaminophen 250 mg Pain reliever
Ibuprofen 125 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
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

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • muscular aches
    • minor pain of arthritis
Section 42229-5 (42229-5)

Drug Facts

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.

Directions
  • do not take more than directed
adults and children 12 years and over    •  take 2 caplets every 8 hourswhile symptoms persist
children under 12 years  • ask a doctor
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
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
Other Information (Other information)
  • read all warnings and directions before use.
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Distributed by:

GSK CH, Warren,

NJ 07059

Packaged and distributed by RJ Corp with the permission of HALEON.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Acetaminophen 250 mg and Ibuprofen 125 mg Tablets - NDC 70264-040-12 -  50 Caplets Carton Label

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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))
Active ingredients (in each tablet) Purpose
Acetaminophen 250 mg Pain reliever
Ibuprofen 125 mg (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
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)