Good Sense Childrens Ibuprofen Tablet, Chewable
FDA Label NDC 0113-6040

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L. Perrigo Company for the product Good Sense Childrens Ibuprofen (NDC 0113-6040). 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 active ingredient (in each chewable tablet), purposes, 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

Active Ingredient (In Each Chewable Tablet)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily:

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

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

  • mouth or throat burning may occur; give with food or water
  • 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

  • chew or crush tablets completely before swallowing
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find right dose on chart below. 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)

    Tablets

    under 24

    under 2

    ask a doctor

    24-35

    2-3

    1

    36-47

    4-5

    1 ½

    48-59

    6-8

    2

    60-71

    9-10

    2 ½

    72-95

    11

    3

Other Information

  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • store between 20-25°C (68-77°F)
  • do not use if printed seal under cap is broken or missing

Inactive Ingredients

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid

Questions Or Comments?

1-800-719-9260

Principal Display Panel

GOODSENSE®

For Ages 2 to 11 Years

Chewables

Lasts Up To 8 Hours

Children’s Ibuprofen

Chewable Tablets, 100 mg

Pain Reliever / Fever Reducer (NSAID)

Grape Flavor

Actual Size

Chew or Crush Tablets Completely Before Swallowing

24 Chewable Tablets

Compare to active ingredient of Children’s Motrin®

100% SATISFACTION GUARANTEED

Pictures\521-c2-childrens-ibuprofen.jpg (521 C2 Childrens Ibuprofen)

Pictures\521-c2-childrens-ibuprofen.jpg (521 C2 Childrens Ibuprofen)

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