Children's Ibuprofen Oral Suspension, Usp

Children's Ibuprofen Oral Suspension, Usp
SPL v1
SPL
SPL Set ID 436c0126-4ff3-c082-e063-6294a90a3d72
Route
ORAL
Published
Effective Date 2025-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin High Fructose Corn Syrup Hypromellose, Unspecified Polysorbate 80 Water Sodium Benzoate Sorbitol Solution Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2011-04-28

Description

Active ingredient (in each 5 mL)………………….………………………………..………..Purpose Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Active ingredient (in each 5 mL)………………….………………………………..………..Purpose Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer *nonsteroidal anti-inflammatory drug

Uses

Temporarily:

  • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
  • reduces fever
Section 42229-5

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
Section 51945-4

NDC: 81033-019-02

CHILDREN'S Ibuprofen Oral Suspension, USP

200 mg per 10 mL

Delivers 10 mL

Case = 100 UD Cups (Do Not Break Case)

Warnings

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.

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.
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day

Dosing Chart
Weight (lb) Age (yr) Dose (mL)
under 24 under 2 years ask a doctor
24 to 35 lbs 2 to 3 years 5 mL
36 to 47 lbs 4 to 5 years 7.5 mL
48 to 59 lbs 6 to 8 years 10 mL
60 to 71 lbs 9 to 10 years 12.5 mL
72 to 95 lbs 11 years 15 mL

*or as directed by a doctor

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
Drug Facts

Active ingredient (in each 5 mL)………………….………………………………..………..Purpose

Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer

*nonsteroidal anti-inflammatory drug

Other Information
  • each 5 mL contains: sodium 2 mg
  • store at 20°C to 25°C (68°F to 77°F)
  • CHILDREN’S Ibuprofen Oral Suspension is a white, berry flavored suspension supplied in the following oral dosage forms:

NDC 81033-019-05: 5 mL unit-dose cup

NDC 81033-019-01: Case containing 100 unit-dose cups of 5 mL each.

NDC 81033-019-10: 10 mL unit-dose cup

NDC 81033-019-02: Case containing 100 unit-dose cups of 10 mL each.

Inactive Ingredients

anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions Or Comments?

Call 1-833-537-4679

Principal Display Panel

NDC: 81033-019-01

CHLIDREN'S Ibuprofen Oral Suspension, USP

100 mg per 5 mL

Delivers 5 mL

Case = 100 UD Cups (Do Not Break Case)

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

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
Section 42229-5 (42229-5)

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
Section 51945-4 (51945-4)

NDC: 81033-019-02

CHILDREN'S Ibuprofen Oral Suspension, USP

200 mg per 10 mL

Delivers 10 mL

Case = 100 UD Cups (Do Not Break Case)

Purpose

Pain reliever/Fever reducer

Warnings

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.

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.
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day

Dosing Chart
Weight (lb) Age (yr) Dose (mL)
under 24 under 2 years ask a doctor
24 to 35 lbs 2 to 3 years 5 mL
36 to 47 lbs 4 to 5 years 7.5 mL
48 to 59 lbs 6 to 8 years 10 mL
60 to 71 lbs 9 to 10 years 12.5 mL
72 to 95 lbs 11 years 15 mL

*or as directed by a doctor

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
Drug Facts

Active ingredient (in each 5 mL)………………….………………………………..………..Purpose

Ibuprofen 100 mg (NSAID)*……………………………………………………………….....…Pain reliever/Fever reducer

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store at 20°C to 25°C (68°F to 77°F)
  • CHILDREN’S Ibuprofen Oral Suspension is a white, berry flavored suspension supplied in the following oral dosage forms:

NDC 81033-019-05: 5 mL unit-dose cup

NDC 81033-019-01: Case containing 100 unit-dose cups of 5 mL each.

NDC 81033-019-10: 10 mL unit-dose cup

NDC 81033-019-02: Case containing 100 unit-dose cups of 10 mL each.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, artificial mixed berry flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-833-537-4679

Principal Display Panel

NDC: 81033-019-01

CHLIDREN'S Ibuprofen Oral Suspension, USP

100 mg per 5 mL

Delivers 5 mL

Case = 100 UD Cups (Do Not Break Case)

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
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)

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)