Advil Capsule, Liquid Filled
FDA Label NDC 0573-0149

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 (NDC 0573-0149). 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 active ingredient (in each capsule), purpose, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
    • temporarily reduces fever

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.

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

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

Ask A Doctor Before Use If

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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
      • fever gets worse or lasts more than 3 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 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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 capsule, 2 capsules may be used
  • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other Information

  • each capsule contains: potassium 20 mg
  • 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)

Advil Liqui-Gels

FD&C green no. 3, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Advil Liqui-Gels Minis

FD&C green no. 3, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions Or Comments?

call toll free 1-800-88-ADVIL

Principal Display Panel - 200 Mg Capsule Pouch

Advil®
LIQUI-GELS®

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

2 Liquid Filled Capsules

Principal Display Panel - 200 Mg Capsule Pouch Box

Advil®
LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

Liquid Filled
Capsules

Principal Display Panel - 80 Capsule Bottle Label

Advil®
LIQUI-GELS®

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

80 Liquid Filled Capsules

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 80 Capsule Bottle Carton

Advil®
LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

80
Liquid Filled
Capsules

Principal Display Panel - 160 Capsule Bottle Label

Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
Use℠
CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®
LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

160
Liquid Filled
Capsules

Principal Display Panel (160 Capsule Bottle Label)

Principal Display Panel (160 Capsule Bottle Label)

Principal Display Panel - 20 Capsule Bottle Label

Advil®
LIQUI•GELS®

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

minis

20 Liquid Filled Capsules

Principal Display Panel - 20 Capsule Bottle Carton

NEW
Smaller
Capsule

Same
Strength

Advil®
LIQUI•GELS®

minis

Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

20
Liquid Filled
Capsules

* Please review the disclaimer below.