Drug Facts

Drug Facts
SPL v19
SPL
SPL Set ID db5ed801-7a7e-3c83-0172-77f914daaa5a
Route
ORAL
Published
Effective Date 2020-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (50 mg)
Inactive Ingredients
Acetic Acid Butylated Hydroxytoluene Carboxymethylcellulose Sodium, Unspecified Citric Acid Monohydrate Edetate Disodium Glycerin Microcrystalline Cellulose Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sorbitol Sucrose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 1998-01-30

Description

Ibuprofen 50 mg (NSAID) nonsteroidal anti-inflammatory drug

Purpose

Fever reducer/Pain reliever


Medication Information

Purpose

Fever reducer/Pain reliever

Description

Ibuprofen 50 mg (NSAID) nonsteroidal anti-inflammatory drug

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, headaches and toothaches
Section 50565-1

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

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • 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
  • measure with the dosing device provided. Do not use with any other device.
Dosing Chart
Weight (lb) Age (mos) Dose (mL)

under 6 mos

ask a doctor

12-17 lb

6-11 mos

1.25 mL

18-23 lb

12-23 mos

1.875 mL

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)
  • see bottom of box for lot number and expiration date
Inactive Ingredients

acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments?

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

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

Principal Display Panel

Infants'

Advil®

Concentrated Drops

Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To

8

Hours

Dye-Free

White Grape Flavored Drops

for ages 6–23 months

1/2 FL OZ (15 mL)

Alcohol-Free

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 the 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
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 1.25 Ml)

Ibuprofen 50 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

temporarily:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, headaches and toothaches
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.

Purpose

Fever reducer/Pain reliever

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • 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
  • measure with the dosing device provided. Do not use with any other device.
Dosing Chart
Weight (lb) Age (mos) Dose (mL)

under 6 mos

ask a doctor

12-17 lb

6-11 mos

1.25 mL

18-23 lb

12-23 mos

1.875 mL

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
  • one dose lasts 6-8 hours
  • store at 20-25°C (68-77°F)
  • see bottom of box for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

acetic acid, artificial flavor, butylated hydroxytoluene, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

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

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Infants'

Advil®

Concentrated Drops

Ibuprofen Oral Suspension

50 mg per 1.25 mL

Pain Reliever/Fever Reducer (NSAID)

Fever

Aches & Pains

Lasts Up To

8

Hours

Dye-Free

White Grape Flavored Drops

for ages 6–23 months

1/2 FL OZ (15 mL)

Alcohol-Free

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 the 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
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 1.25 Ml) (Active ingredient (in each 1.25 mL))

Ibuprofen 50 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

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