Advil ®

Advil ®
SPL v12
SPL
SPL Set ID 772360bd-8631-4d24-b4db-5a7e6e1d9a13
Route
ORAL
Published
Effective Date 2022-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Diacetylated Monoglycerides Silicon Dioxide Starch, Corn Croscarmellose Sodium Methylparaben Microcrystalline Cellulose Shellac Povidone, Unspecified Propylparaben Sodium Benzoate Sodium Lauryl Sulfate Stearic Acid Sucrose Titanium Dioxide White Wax

Identifiers & Packaging

Pill Appearance
Imprint: Advil Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
NDA Completed Since 2022-11-29 Until 2014-03-05

Description

Drug Facts

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

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 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.

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
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.

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 Ingredients

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

Questions Or Comments?

call toll free 1-800-88-ADVIL

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
Cvp Health Advil Pdp/package

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Tablets

4

Coated

Tablets

[CVP ® Health logo]

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.

Travel Basix Advil Pdp/package

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Tablets

4

Coated

Tablets

[Travel BASIX logo]

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID)

nonsteroidal anti-inflammatory drug

Lil' Drug Store Advil Pdp/package

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

[tablet image]

6

Coated

Tablets

Lil' Drug Store ®

Advil 30pc Dispens It Box, Lil' Drug Store ®

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[tablet image]

Tablets

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

See full Drug Facys information

on the back of this dispenser

60 TABLETS

(30 PACKETS OF 2 COATED TABLETS EACH)

[Lil' Drug Store ® logo]

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

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
Section 42229-5 (42229-5)

Drug Facts

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 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.

Purpose

Pain reliever/Fever reducer

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
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.

Other Information (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 Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

call toll free 1-800-88-ADVIL

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
Cvp Health Advil Pdp/package (CVP Health Advil - PDP/Package)

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Tablets

4

Coated

Tablets

[CVP ® Health logo]

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.

Travel Basix Advil Pdp/package (Travel BASIX Advil - PDP/Package)

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

[tablet image]

Tablets

4

Coated

Tablets

[Travel BASIX logo]

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Ibuprofen 200 mg (NSAID)

nonsteroidal anti-inflammatory drug

Lil' Drug Store Advil Pdp/package (Lil' Drug Store Advil - PDP/Package)

Advil ®

Ibuprofen Tablets, 200 mg

Pain Reliever / Fever Reducer (NSAID)

[tablet image]

6

Coated

Tablets

Lil' Drug Store ®

Advil 30pc Dispens It Box, Lil' Drug Store ® (Advil 30pc Dispens-It Box, Lil' Drug Store ®)

Advil

Ibuprofen Tablets, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[tablet image]

Tablets

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

See full Drug Facys information

on the back of this dispenser

60 TABLETS

(30 PACKETS OF 2 COATED TABLETS EACH)

[Lil' Drug Store ® logo]

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

All Sections (JSON)