Dye Free Children's Ibuprofen Oral Suspension

Dye Free Children's Ibuprofen Oral Suspension
SPL v7
SPL
SPL Set ID eccee4c6-aa94-468a-aebd-265d7a9efb6d
Route
ORAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2015-08-26

Description

Berry Flavor 100 mg/5 mL For Hospital Use Only LI1653 Rev. 10/24 Drug Facts

Purpose

Pain reliever/fever reducer

How Supplied

NDC 68094-600-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-600-62 5 mL per unit dose cup Thirty (30) cups per shipper


Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

NDC 68094-600-61

5 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-600-62

5 mL per unit dose cup

Thirty (30) cups per shipper

Description

Berry Flavor 100 mg/5 mL For Hospital Use Only LI1653 Rev. 10/24 Drug Facts

Uses

temporarily:

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

Berry Flavor

100 mg/5 mL

For Hospital Use Only

LI1653 Rev. 10/24

Drug Facts

Section 50565-1

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)

Purposes

Pain reliever/fever reducer

Directions
  • use as directed per healthcare professional
  • 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 lbs 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.

Other Information
  • each 5 mL contains: sodium 2 mg
  • store at 20-25°C (68-77°F)
  • do not freeze
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.

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?

1-800-397-9228

When Using This Product
  • give 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
Active Ingredient (in Each 5 Ml)

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Heart Attack and Stroke Warnings

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.

Principal Display Panel 100 Mg/5 Ml Cup Label

NDC 68094-600-59

PrecisionDose™

Children's IBUPROFEN

Oral Suspension

100 mg/5 mL

DYE

FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

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)

Berry Flavor

100 mg/5 mL

For Hospital Use Only

LI1653 Rev. 10/24

Drug Facts

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. (1-800-222-1222)

Purposes

Pain reliever/fever reducer

Directions
  • use as directed per healthcare professional
  • 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 lbs 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
How Supplied

NDC 68094-600-61

5 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-600-62

5 mL per unit dose cup

Thirty (30) cups per shipper

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)
  • each 5 mL contains: sodium 2 mg
  • store at 20-25°C (68-77°F)
  • do not freeze
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.

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?)

1-800-397-9228

When Using This Product (When using this product)
  • give 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
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug

Heart Attack and Stroke Warnings (Heart attack and stroke warnings)

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.

Principal Display Panel 100 Mg/5 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Cup Label)

NDC 68094-600-59

PrecisionDose™

Children's IBUPROFEN

Oral Suspension

100 mg/5 mL

DYE

FREE

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

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)