Advil Dual Action With Acetaminophen Tablet, Film Coated
FDA Label NDC 0573-0147

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Advil Dual Action With Acetaminophen (NDC 0573-0147). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, indications & usage, warnings, acetaminophen liver damage warning, nsaid stomach bleeding warning, heart attack and stroke warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

Otc - Purpose

Active ingredients (in each caplet)Purposes
Acetaminophen 250 mgPain reliever
Ibuprofen 125 mg (NSAID

nonsteroidal anti-inflammatory drug

)		Pain reliever

Indications & Usage

Uses

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

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

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

Otc - Pregnancy Or Breast Feeding

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.

Otc - 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.

Dosage & Administration

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

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

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

Otc - Questions

Questions or comments?

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

Principal Display Panel - 18 Caplet Bottle Label

CONTAINS 2 MEDICINES

Advil®
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

18
Caplets

Principal Display Panel - 18 Caplet Bottle Carton

NEW
Advil®
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

18
Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 144 Caplet Bottle Label

CONTAINS 2 MEDICINES

Advil®
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

144
Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 144 Caplet Bottle Carton

NEW
Advil®
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

144
Caplets*
*Capsule-Shaped Tablets

Principal Display Panel - 2 Caplet Packet

Advil®
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

2
Caplets

Do not use with other medicines
containing ACETAMINOPHEN;
can cause liver damage.

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

PAA117156

TO OPEN: FOLD BACK ON DOTTED LINE.
TEAR ON ARROW OR USE SCISSORS.
Do Not Use if pouch is broken or torn.

Principal Display Panel - 50 Packet Carton

NEW
Advil®
DUAL ACTION
WITH Acetaminophen

Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen

✓Headache
✓Menstrual Cramps
✓Muscular Aches
✓Toothache
✓Minor Pain of Arthritis

See full Drug Facts information
on the back of this dispenser

50 Packets of
2 Caplets* Each
*Capsule-Shaped Tablets

* Please review the disclaimer below.