CHILDRENS MOTRIN- ibuprofen tablet, chewable 
Johnson & Johnson Consumer Inc.

----------

Children's Motrin

Drug Facts

Active ingredient (in each chewable tablet)

Ibuprofen 100 mg (NSAID) 1


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

Inactive ingredients

acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, 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

NDC 50580-932-01

For Ages 2 to 11 Years

Children's
Motrin ®

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

DYE-FREE

Lasts up to 8 hours

Actual Size

Chew or crush tablets
completely before swallowing

24
Grape-Flavored Chewable Tablets

motrin-01

CHILDRENS MOTRIN 
ibuprofen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-932
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)  
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
Colorwhite (Off White) Score2 pieces
ShapeROUNDSize13mm
FlavorGRAPEImprint Code M;100
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-932-011 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. (878046358)

Revised: 3/2023
Document Id: f7b5e3b5-fc6f-e72f-e053-6294a90aa1e4
Set id: 15b0b56d-6188-4937-b541-902022e35b24
Version: 5
Effective Time: 20230325
 
Johnson & Johnson Consumer Inc.