Childrens Ibuprofen Suspension
FDA Label NDC 68001-521

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Childrens Ibuprofen (NDC 68001-521). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if the child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each 5 mL)

Ibuprofen USP 100 mg (NSAID)*

Purpose

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

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.

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

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

Ask A Doctor Or Pharmacist Before Use If The Child Is

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

When Using This Product

  • take with food or milk if stomach upset occurs

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)

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.
  • use only enclosed dosing cup. Do not use any other dosing device.
  • if needed, repeat dose every 6 to 8 hours
  • do not use more than 4 times a day
  • replace original bottle cap to maintain child resistance
  • wash dosage cup after each use

    • Dosing Chart
    * or as directed by a doctor
    Weight (lb)
    		Age (year)
    		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

Other Information

  • each 5 mL contains: sodium 2 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not use if carton is opened or seal under cap opening is broken or missing
  • see bottom panel for lot number and expiration date

Inactive Ingredients

Acesulfame potassium, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, N&A flavor for cherry blast, N&A strawberry flavor wild, polysorbate 80, pregelatinized starch (potato), propylene glycol, purified water, sodium benzoate, sucrose and xanthan gum

Package Label-Principal Display Panel 4 Fl Oz (120 Ml) Container Label

NDC 68001-521-92

For Ages 2 to 11 Years

Children’s

Ibuprofen

Oral Suspension USP

100 mg per 5 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to

8 hours

Alcohol Free

Berry Flavor

4 FL OZ (120 mL)

Package Label-Principal Display Panel 4 Fl Oz (120 Ml) Carton Label

NDC 68001-521-92

#Compare to the active ingredient

in Children's Motrin ®

For Ages 2 to 11 Years

Children’s

Ibuprofen

Oral Suspension USP

100 mg per 5 mL

Pain Reliever/Fever Reducer (NSAID)

Lasts up to

8 hours

Alcohol Free

Berry Flavor

4 FL OZ (120 mL)

* Please review the disclaimer below.