Children's Ibuprofen Oral Suspension Usp

Children's Ibuprofen Oral Suspension Usp
SPL v1
SPL
SPL Set ID bc69d88b-d9af-4010-8e8f-e761a9e295a9
Route
ORAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (100 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Microcrystalline Cellulose Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-12-01
Description

Important: Read all product information before using. Keep this insert for important information. This product is intended for use in children.

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Important: Read all product information before using. Keep this insert for important information. This product is intended for use in children.

Uses

temporarily:

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

Important: Read all product information before using. Keep this insert for important information. This product is intended for use in children.

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.

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

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.

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.

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. If possible, use weight to dose; otherwise use age.
  • if needed repeat dose every 6–8 hours
  • do not use more than 4 times a day
Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)

or as directed by a doctor

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL (1 unit dose cup)

36-47 lbs

4-5 years

7.5 mL (1.5 unit dose cups)

48-59 lbs

6-8 years

10 mL (2 unit dose cups)

60-71 lbs

9-10 years

12.5 mL (2.5 unit dose cups)

72-95 lbs

11 years

15 mL (3 unit dose cups)
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
Other Information
  • each 5 mL contains: sodium 2 mg
  • store between 20° to 25°C (68° to 77°F)

Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms:

5 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐743‐17

Inactive Ingredients:

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

Questions Or Comments?

Call 1-800-845-8210.

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)

Active Ingredient (in Each 5 Ml Cup)

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel – Tray Label

Case NDC 60687-743-17/Cup NDC 60687-743-40

Children’s Ibuprofen

Oral Suspension, USP

(NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

Berry Flavored/Dye Free/Alcohol Free

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T1022C050723            R07/23

Principal Display Panel – Cup 100 Mg / 5 Ml

NDC 60687- 743-40

Children's Ibuprofen

Oral Suspension, USP

(NSAID)

Pain Reliever/Fever Reducer

100 mg per 5 ml

Berry Flavored/Dye Free/ Alcohol Free

Delivers 5 mL

SHAKE WELL

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

A1022C05/1023

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)

Important: Read all product information before using. Keep this insert for important information. This product is intended for use in children.

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.

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

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.

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.

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. If possible, use weight to dose; otherwise use age.
  • if needed repeat dose every 6–8 hours
  • do not use more than 4 times a day
Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)

or as directed by a doctor

under 24

under 2 years

ask a doctor

24-35 lbs

2-3 years

5 mL (1 unit dose cup)

36-47 lbs

4-5 years

7.5 mL (1.5 unit dose cups)

48-59 lbs

6-8 years

10 mL (2 unit dose cups)

60-71 lbs

9-10 years

12.5 mL (2.5 unit dose cups)

72-95 lbs

11 years

15 mL (3 unit dose cups)
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
Other Information (Other information)
  • each 5 mL contains: sodium 2 mg
  • store between 20° to 25°C (68° to 77°F)

Children’s Ibuprofen Oral Suspension is a clear, berry flavored suspension supplied in the following oral dosage forms:

5 mL unit dose cups: 100 cups (10 x 10) NDC 60687‐743‐17

Inactive Ingredients: (Inactive ingredients:)

Acesulfame potassium, anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210.

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)

Active Ingredient (in Each 5 Ml Cup) (Active ingredient (in each 5 mL cup))

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Principal Display Panel – Tray Label

Case NDC 60687-743-17/Cup NDC 60687-743-40

Children’s Ibuprofen

Oral Suspension, USP

(NSAID)

100 mg per 5 mL

Pain Reliever/Fever Reducer

Berry Flavored/Dye Free/Alcohol Free

SHAKE WELL

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

For Institutional Use Only.

T1022C050723            R07/23

Principal Display Panel – Cup 100 Mg / 5 Ml (Principal Display Panel – Cup - 100 mg / 5 mL)

NDC 60687- 743-40

Children's Ibuprofen

Oral Suspension, USP

(NSAID)

Pain Reliever/Fever Reducer

100 mg per 5 ml

Berry Flavored/Dye Free/ Alcohol Free

Delivers 5 mL

SHAKE WELL

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

A1022C05/1023

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.743143 · Updated: 2026-03-14T23:02:00.533418