Childrens Ibuprofen Oral Suspension
FDA Label NDC 0121-1828

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmaceutical Associates, Inc. for the product Childrens Ibuprofen Oral Suspension (NDC 0121-1828). 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 other, active ingredient (in each 5 ml), uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, sore throat warning, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each 5 Ml)

Uses

temporarily:

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

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

Otc - 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 (1-800-222-1222) 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. 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)*
    under 24under 2 yearsask a doctor
    24-35 lbs2-3 years5 mL
    36-47 lbs4-5 years7.5 mL
    48-59 lbs6-8 years10 mL
    60-71 lbs9-10 years12.5 mL
    72-95 lbs11 years15 mL

    *or as directed by a doctor

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 purple, grape flavored suspension supplied in the following oral dosage forms:

    NDC 0121-1828-10:  10 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

acesulfame potassium, artificial grape flavor, citric acid anhydrous, D&C red #33, FD&C blue #1, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

†This product is not manufactured or distributed by McNeil Consumer
Healthcare, distributor of Children’s Motrin®

Principal Display Panel

Delivers 5 mL

NDC 0121-0914-05

Children's Ibuprofen Oral Suspension, USP

(NSAID)

100 mg per 5 mL

Pain reliever/Fever reducer

Grape/Flavored/Alcohol Free

SHAKE WELL

FOR INSTITUTIONAL USE ONLY

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

Delivers 10 mL

NDC 0121-1828-10

Children's Ibuprofen Oral Suspension, USP

(NSAID)

200 mg per 10 mL

Pain reliever/Fever reducer

Grape/Flavored/Alcohol Free

SHAKE WELL

FOR INSTITUTIONAL USE ONLY

Pkg. by: Pharmaceutical Associates, Inc.

Greenville, SC 29680

* Please review the disclaimer below.