Advil Ibu Sodium Ndc 0573-0133, 0573-0134

Advil Ibu Sodium Ndc 0573-0133, 0573-0134
SPL v20
SPL
SPL Set ID 5be198b8-396e-4b44-8819-e2e3b5d2ad0e
Route
ORAL
Published
Effective Date 2022-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (256 mg)
Inactive Ingredients
Acesulfame Potassium Caramel Carnauba Wax Silicon Dioxide Copovidone K25-31 Ferric Oxide Red Hypromellose, Unspecified Mannitol Medium-chain Triglycerides Microcrystalline Cellulose Polyethylene Glycol, Unspecified Propylene Glycol Sodium Lauryl Sulfate Sucralose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Advil;asymmetrical;underline Shape: round Shape: oval Color: brown Size: 10 mm Size: 15 mm Score: 1
Marketing Status
NDA Active Since 2013-07-08

Description

Active ingredient (in each tablet) Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)* *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

Warnings

Indications and 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
Dosage and 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
Description

Active ingredient (in each tablet) Ibuprofen 200 mg (provided as ibuprofen sodium 256 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Section 44425-7

Other information

  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Section 50565-1

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

Section 51727-6

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

Section 53413-1

Questions or comments?

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

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever/ Fever reducer

Section 55106-9

Active ingredient (in each tablet)

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

*nonsteroidal anti-inflammatory drug

Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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.

Additional Information

Do Not Use if the sealed child resistant pouch is broken or torn.

For most recent product information, visit www.Advil.com

Principal Display Panel

Advil

FILM-COATED

IBUPROFEN

SODIUM

Ibuprofen Tablets, 200 mg

(Provided as Ibuprofen Sodium 256 mg)

Pain Reliever / Fever Reducer (NSAID)

Advil Tablets

  • Headache
  • Muscular Aches
  • Minor Pain of Arthritis
  • Menstrual Cramps
  • Toothache
  • Fever

See Full Drug Facts information on the back of this dispenser

100 TABLETS

(50 PACKETS of 2 TABLETS EACH)

000068427 Front Carton

When Using This Product
  • take with food or milk if stomach upset occurs
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
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
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
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.

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

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever/ Fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

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

*nonsteroidal anti-inflammatory drug

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert: (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.

Additional Information

Do Not Use if the sealed child resistant pouch is broken or torn.

For most recent product information, visit www.Advil.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Advil

FILM-COATED

IBUPROFEN

SODIUM

Ibuprofen Tablets, 200 mg

(Provided as Ibuprofen Sodium 256 mg)

Pain Reliever / Fever Reducer (NSAID)

Advil Tablets

  • Headache
  • Muscular Aches
  • Minor Pain of Arthritis
  • Menstrual Cramps
  • Toothache
  • Fever

See Full Drug Facts information on the back of this dispenser

100 TABLETS

(50 PACKETS of 2 TABLETS EACH)

000068427 Front Carton

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning: (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
Ask A Doctor Before Use If (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
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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
Heart Attack and Stroke Warning (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.

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

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