Advil Tablet, Coated
FDA Label NDC 0573-0133

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 0573-0133). 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 - active ingredient, otc - purpose, indications & usage, warnings, 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (in each tablet)

Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)

nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose

Pain reliever/ Fever reducer

Indications & Usage

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

Warnings

Warnings

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

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
  • 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

Storage And Handling

Other information

  • each tablet contains: sodium 22 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)

Inactive Ingredient

Inactive ingredients

acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

Otc - Questions

Questions or comments?

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

For most recent product information, visit www.Advil.com
Pfizer, Madison, NJ 07940 USA

Principal Display Panel - 20 Tablet Bottle Label

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

20 Coated Tablets

Principal Display Panel - 20 Tablet Bottle Carton

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Tablets

20 Coated Tablets

Principal Display Panel - 80 Tablet Bottle Label

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

80 Tablets

Principal Display Panel - 80 Tablet Bottle Carton

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Tablets

80 Tablets

Principal Display Panel (80 Tablet Bottle Carton)

Principal Display Panel (80 Tablet Bottle Carton)

Principal Display Panel - 2 Tablet Packet

Advil®

Ibuprofen Tablets 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever/Fever Reducer (NSAID)

2 Coated Tablets
200 mg Each

Principal Display Panel - 50 Packet Tray

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Tablets

✔ Headache

✔ Muscular Aches

✔ Minor Pain of Arthritis

✔ Menstrual Cramps

✔ Toothache

✔ Fever

See Full Drug
Facts information
on the back of
this dispenser

50 PACKETS of
2 COATED TABLETS EACH

Principal Display Panel - 4 Tablet Blister Pack

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

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Go to Advil.com
for a coupon good on
your next purchase!

Tablets

4 Coated Tablets

Principal Display Panel - 2 X 120 Bottle Carton

Advil®

2
PACK
2x120
TABLETS

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Tablets

FILM-COATED
IBUPROFEN SODIUM

240 Coated Tablets
2 x 120 Count Bottles

Principal Display Panel - 20 Caplet Bottle Label

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN SODIUM

20 Caplets**

**capsule-shaped tablets

Principal Display Panel - 20 Caplet Bottle Carton

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Caplets**

20 Coated Caplets**
**capsule-shaped tablets

Principal Display Panel - 80 Caplet Bottle Label

Advil®

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

FILM-COATED
IBUPROFEN
SODIUM

80 Caplets**

**capsule-shaped tablets

Principal Display Panel - 80 Caplet Bottle Carton

Advil®

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Caplets**

80 Coated Caplets**
**capsule-shaped tablets

* Please review the disclaimer below.