Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 5ed0d404-c54d-b05f-578a-d2730e8a78ee
Route
ORAL
Published
Effective Date 2020-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Diacetylated Monoglycerides Carnauba Wax Silicon Dioxide Starch, Corn Croscarmellose Sodium Methylparaben Microcrystalline Cellulose Shellac Povidone, Unspecified Propylparaben Sodium Benzoate Stearic Acid Sucrose Ferric Oxide Red Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: Advil;100 Shape: round Color: brown Size: 8 mm Score: 1
Marketing Status
NDA Active Since 2011-06-21

Description

Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Fever reducer/Pain reliever


Medication Information

Purpose

Fever reducer/Pain reliever

Description

Ibuprofen 100 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • repeat dose every 6-8 hours, if needed
  • do not use more than 4 times a day
Dosing Chart
Weight (lb) Age (yr) Dose (tablets)

under 48 lb

under 6 yr

ask a doctor

48-71 lb

6-10 yr

2 tablets

72-95 lb

11 yr

3 tablets

Do Not Use
  • if the child has 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
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • see side of box for lot number and expiration date
Inactive Ingredients

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

Sore Throat Warning:

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Questions Or Comments?

call toll free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

Principal Display Panel

Junior Strength

Advil ®

Ibuprofen Tablets, 100 mg

Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To

8

Hours

for ages 6-11 years

24 COATED

TABLETS

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 the child

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • takes more or for a longer time than directed
Ask A Doctor Before Use If
  • stomach bleeding warning applies to the child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has a history of stomach problems, such as heartburn
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child is taking a diuretic
Stop Use and Ask A Doctor If
  • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
  • child has symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
Keep Out of Reach of Children

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

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.

Active Ingredient (in Each Tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If the Child Is
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses (USES)

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purpose (PURPOSE)

Fever reducer/Pain reliever

Directions (DIRECTIONS)
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • repeat dose every 6-8 hours, if needed
  • do not use more than 4 times a day
Dosing Chart
Weight (lb) Age (yr) Dose (tablets)

under 48 lb

under 6 yr

ask a doctor

48-71 lb

6-10 yr

2 tablets

72-95 lb

11 yr

3 tablets

Do Not Use (Do not use)
  • if the child has 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)
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • see side of box for lot number and expiration date
Inactive Ingredients (INACTIVE INGREDIENTS)

acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide

Sore Throat Warning: (Sore throat warning:)

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call toll free 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Junior Strength

Advil ®

Ibuprofen Tablets, 100 mg

Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To

8

Hours

for ages 6-11 years

24 COATED

TABLETS

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 the child

  • has had stomach ulcers or bleeding problems
  • takes a blood thinning (anticoagulant) or steroid drug
  • takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • takes 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 the child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has a history of stomach problems, such as heartburn
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child is taking a diuretic
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • child experiences any of the following signs of stomach bleeding:
    • feels faint
    • vomits blood
    • has bloody or black stools
    • has stomach pain that does not get better
  • child has symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling
  • child does not get any relief within first day (24 hours) of treatment
  • fever or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
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.

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.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)