Children's Ibuprofen Oral Suspension, Usp

Children's Ibuprofen Oral Suspension, Usp
SPL v2
SPL
SPL Set ID 7d4ba8be-df59-4a21-8850-8a59bf72b604
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Glycerin Hydroxypropyl Methylcellulose Peg-20 Sorbitan Oleate Sodium Benzoate Sucrose Water Xanthan Gum Propylene Glycol Triacetin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2024-08-15

Description

(in each 5 ml) Ibuprofen 100 mg (NSAID) *   *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

(in each 5 ml) Ibuprofen 100 mg (NSAID) *   *nonsteroidal anti-inflammatory drug

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • remove bottle cap and squeeze your child's dose into the dosing cup
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
   Dosing Chart

*or as directed by a doctor

 Weight (lb)

 Age (yr)

 Dose (mL)*

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15 mL

Do Not Use
  • if the child has ever had an allergic reaction to ibuprofen or 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.

Active Ingrident

(in each 5 ml)

Ibuprofen 100 mg (NSAID)* 

*nonsteroidal anti-inflammatory drug

Other Information
  • each 5 mL contains:sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
Inactive Ingredents

acesulfame potassium, anhydrous citric acid, glycerin, hypromellose, mix berry flavor, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Ibuprofen Suspension
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 1-877-244-9825

*All trademarks are the property of their respective owners.

 

Manufactured for:

Taro Pharmaceuticals U.S.A., Inc.

Hawthrone, NY 10532

TARO is a registered trademark of

Taro Pharmaceuticals U.S.A., Inc.

Made in India

Revised: 08/2024

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 your 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 your child
  • child has a history of stomach problems, such as heartburn
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
  • child has asthma
  • 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
  • the 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. (1-800-222-1222)

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 the Child Is
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses

temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • remove bottle cap and squeeze your child's dose into the dosing cup
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6-8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
   Dosing Chart

*or as directed by a doctor

 Weight (lb)

 Age (yr)

 Dose (mL)*

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL

36-47 lbs

4-5 years

7.5 mL

48-59 lbs

6-8 years

10 mL

60-71 lbs

9-10 years

12.5 mL

72-95 lbs

11 years

15 mL

Do Not Use (Do not use)
  • if the child has ever had an allergic reaction to ibuprofen or 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.

Active Ingrident (Active ingrident)

(in each 5 ml)

Ibuprofen 100 mg (NSAID)* 

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • each 5 mL contains:sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
Inactive Ingredents

acesulfame potassium, anhydrous citric acid, glycerin, hypromellose, mix berry flavor, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum

Ibuprofen Suspension (IBUPROFEN suspension)
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 1-877-244-9825

*All trademarks are the property of their respective owners.

 

Manufactured for:

Taro Pharmaceuticals U.S.A., Inc.

Hawthrone, NY 10532

TARO is a registered trademark of

Taro Pharmaceuticals U.S.A., Inc.

Made in India

Revised: 08/2024

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 your 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 your child
  • child has a history of stomach problems, such as heartburn
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • child has not been drinking fluids
  • child has lost a lot of fluid due to vomiting or diarrhea
  • child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
  • child has asthma
  • 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
  • the 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. (1-800-222-1222)

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 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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