Advil Tablet, Coated
FDA Label NDC 0573-0165

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 0573-0165). 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 advil tablets (in each tablet), advil caplets (in each caplet), advil gel caplets (in each gel caplet), purpose, uses, allergy alert:, stomach bleeding warning:, heart attack and stroke warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Advil Tablets (In Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Advil Caplets (In Each Caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Advil Gel Caplets (In Each Gel Caplet)

Ibuprofen 200 mg (NSAID)*

*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 non-prescription 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.

Advil Tablets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
  • acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Advil Caplets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
  • acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Advil Gel Caplets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
  • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor
  • colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40, FD&C yellow no. 6, fractionated coconut oil, gelatin, glycerin, hypromellose, pharmaceutical ink, pregelatinized starch, propyl gallate, purified water, sodium lauryl sulfate, stearic acid, synthetic iron oxides, titanium dioxide, triacetin

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)

Questions Or Comments?

call toll free 1-800-88-ADVIL

Principal Display Panel - 200 Mg Gel Caplet Bottle Label

Advil®

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

100 Gel Caplets
Gel Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Principal Display Panel - 100 Count 200 Mg Gel Caplet Bottle Carton

Advil®

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

100 Coated Gel Caplets*
*Capsule-Shaped Gelatin-Coated Tablets

Gel
Caplets

Principal Display Panel - 2 Count 200 Mg Tablet Pouch

Advil®

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

2 Coated Tablets

Principal Display Panel - 50 Pouch Dispenser

Advil®

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

Tablets

  • 1.Headache
  • 2.Minor Pain of Arthritis
  • 3.Toothache
  • 4.Muscular Aches
  • 5.Menstrual Cramps
  • 6.Fever
  • 50 PACKETS OF 2 COATED TABLETS EACH

Principal Display Panel - 300 Tablet Bottle Label - Ndc 0573-0154-98

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

300 Coated Tablets

Tablets

Principal Display Panel (300 Tablet Bottle Label)

Principal Display Panel (300 Tablet Bottle Label)

Principal Display Panel - 200 Count 200 Mg Tablet Bottle Label

New Easy Open
ARTHRITIS CAP

Arthritis Foundation
Ease of
UseSM
CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Advil®

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

200 Coated Tablets

Tablets

Principal Display Panel - 10 Tablet Vial Label

Advil®

Tablets

Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)
10 Coated Tablets

Principal Display Panel - 200 Mg Tablet Vial Label

Advil ®

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

10 Tablets

Tablets

Principal Display Panel - 10 Tablet Package

Pocket
Pack

Do not use if blister is open or the
words "ADVIL SAFETY SEALED"
under blister are missing or torn.

Advil®

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

10 Coated Tablets

Tablets

Principal Display Panel - 115 Tablet Bottle Label

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

115 Tablets

Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Principal Display Panel - 115 Tablet Bottle Carton - Ndc 0573-0151-05

15
FREE
TABLETS

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

115
Coated Tablets

Tablets

Principal Display Panel (115 Tablet Bottle Carton)

Principal Display Panel (115 Tablet Bottle Carton)

Principal Display Panel - 225 Caplet Bottle Label

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

225 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 225 Caplet Bottle Carton - Ndc 0573-0161-85

25
FREE
CAPLETS

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

225
Coated Caplets*
*Capsule-Shaped Tablets

Caplets

Principal Display Panel (225 Caplet Bottle Carton)

Principal Display Panel (225 Caplet Bottle Carton)

Principal Display Panel - 24 Tablet Bottle Label

Advil®

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

24 Tablets

Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 24 Tablet Bottle Carton - Ndc 0573-0150-20

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

24 Coated Tablets

Tablets

Principal Display Panel - 100 Tablet Bottle Label

Advil®

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

100 Tablets
Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Tablets

Tablets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Principal Display Panel (100 Tablet Bottle Label)

Principal Display Panel (100 Tablet Bottle Label)

Principal Display Panel - 100 Count 200 Mg Tablet Bottle Carton

Advil®

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

100 Coated Tablets

Tablets

Principal Display Panel - 100 Coated Tablet Bottle Carton - Ndc 0573-0150-40

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

100 Coated Tablets

Tablets

Principal Display Panel - 24 Caplet Bottle Label

Advil®

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

24 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 24 Caplet Bottle Carton - Ndc 0573-0160-20

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

24 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

Principal Display Panel - 200 Mg Caplet Bottle Label

Advil®

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

100 Caplets
Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Do Not Use if seal under bottle cap imprinted with
"SEALED for YOUR PROTECTION" is broken or missing.

Principal Display Panel - 100 Count 200 Mg Caplet Bottle Carton

Advil®

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

50 Coated Caplets*
*Capsule-Shaped Tablets

Caplets

Principal Display Panel - 36 Caplet Bottle Label

Advil®

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

36 Caplets

Caplets

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Principal Display Panel - 36 Caplet Bottle Carton - Ndc 0573-0160-25

50%
MORE
FREE

12 Free
Caplets

Advil®
Ibuprofen Tablets, 200 mg
Pain Reliever/Fever Reducer (NSAID)

36
Coated Caplets*
*Capsule-Shaped Tablets

Caplets

* Please review the disclaimer below.