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  5. Label Information: Childrens Motrin

FDA Label for Childrens Motrin

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET)
    3. PURPOSE
    4. USES
    5. ALLERGY ALERT
    6. STOMACH BLEEDING WARNING
    7. HEART ATTACK AND STROKE WARNING
    8. SORE THROAT WARNING
    9. DO NOT USE
    10. ASK A DOCTOR BEFORE USE IF
    11. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    12. WHEN USING THIS PRODUCT
    13. STOP USE AND ASK A DOCTOR IF
    14. OTC - KEEP OUT OF REACH OF CHILDREN
    15. DIRECTIONS
    16. OTHER INFORMATION
    17. INACTIVE INGREDIENTS
    18. QUESTIONS?
    19. PRINCIPAL DISPLAY PANEL

Childrens Motrin Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient (In Each Chewable Tablet)



Ibuprofen 100 mg (NSAID)

nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/fever reducer


Uses



temporarily:

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

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

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 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 24under 2ask a doctor
    24-352-31
    36-474-51 ½
    48-596-82
    60-719-102 ½
    72-95113

Other Information



  • phenylketonurics: contains phenylalanine 6 mg per tablet
  • store between 20-25°C (68-77°F)

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?



Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com


Principal Display Panel



Children's
Motrin®

NDC 50580-933-01

For Ages 2 to 11 Years

Lasts up to
8 hours

Ibuprofen Chewable Tablets,100 mg
Pain Reliever / Fever Reducer (NSAID)
Chewables

Actual Size

24
Grape-Flavored
Chewable Tablets

Chew or crush tablets
completely before swallowing

PRINCIPAL DISPLAY PANEL - motrin 01

PRINCIPAL DISPLAY PANEL - motrin 01


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