CHILDRENS MOTRIN- ibuprofen tablet, chewable

Childrens Motrin by

Drug Labeling and Warnings

Childrens Motrin by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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
  • 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 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
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MOTRIN 
    ibuprofen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50580-933
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen100 mg
    Inactive Ingredients
    Ingredient NameStrength
    acesulfame potassium (UNII: 23OV73Q5G9)  
    ammonium glycyrrhizate (UNII: 3VRD35U26C)  
    aspartame (UNII: Z0H242BBR1)  
    carnauba wax (UNII: R12CBM0EIZ)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    D&C red no. 27 aluminum lake (UNII: ZK64F7XSTX)  
    FD&C blue no. 1--aluminum lake (UNII: J9EQA3S2JM)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    mannitol (UNII: 3OWL53L36A)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    soybean oil (UNII: 241ATL177A)  
    succinic acid (UNII: AB6MNQ6J6L)  
    Product Characteristics
    ColorPURPLE (lavender) Score2 pieces
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code M;100
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 50580-933-011 in 1 CARTON06/17/2019
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07635906/17/2019
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

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