Home > Drugs A-Z > Infants Motrin

Infants Motrin (McNeil Consumer Healthcare Div McNeil-PPC, Inc)

Available Formats

Dosage Form Package Information Links
SUSPENSION/ DROPS 1 BOTTLE in 1 CARTON (50580-100-18) > 15 mL in 1 BOTTLE Label Information

Complete Infants Motrin Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)1


    1
    • 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

  • 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
    • find right dose on chart below. If possible, use weight to dose; otherwise use age.
    • mL = milliliter
    • measure with the dosing device provided. Do not use with any other device.
    • dispense liquid slowly into the child's mouth, toward the inner cheek
    • if needed, repeat dose every 6-8 hours
    • do not use more than 4 times a day
    Dosing Chart
    Weight (lb) Age (mos) Dose (mL)
    under 6 mos ask a doctor
    12-17 lbs 6-11 mos 1.25 mL
    18-23 lbs 12-23 mos 1.875 mL

  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if carton tape imprinted "SAFETY SEAL®" or bottle wrap imprinted "SAFETY SEAL®" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing

  • Inactive ingredients

    anhydrous citric acid, caramel, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum


  • Questions or comments?

    Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)


  • PRINCIPAL DISPLAY PANEL

    See New Warnings

    NDC 50580-100-18

    For Ages 6 Mos. to 23 Mos.

    Concentrated
    Motrin
    ®
    Infants' Drops

    contains Ibuprofen
    Oral Suspension (NSAID)
    50 mg per 1.25 mL

    Pain Reliever/Fever Reducer

    Lasts up to
    8 hours

    Use only with
    enclosed syringe.

    Original
    Berry Flavor

    1/2 fl oz (15 ml)

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    INFANTS MOTRIN 
    ibuprofen suspension/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 50 mg  in 1.25 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    caramel (UNII: T9D99G2B1R)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    Color PINK Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-100-18 1 in 1 CARTON 05/15/2012
    1 15 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020603 06/01/2004
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)