CHILDRENS MOTRIN- ibuprofen suspension 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Children's MOTRIN

Drug Facts

Active ingredient (in each 5 mL)

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

  • 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) Dose (mL)*
*
or as directed by a doctor
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL
36-47 lbs 4-5 years 7.5 mL
48-59 lbs 6-8 years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 mL

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, 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 50580-601-20

For Ages 2 to 11 Years

Children's
Motrin
®

contains Ibuprofen
Oral Suspension
(NSAID)
100 mg per 5 mL

Pain Reliever / Fever Reducer

Lasts up to
8 hours

Alcohol Free

Original
Berry Flavor

4 fl oz (120 mL)

Principal Display Panel
CHILDRENS MOTRIN 
ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-601
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
acesulfame potassium (UNII: 23OV73Q5G9)  
anhydrous citric acid (UNII: XF417D3PSL)  
D&C yellow no. 10 (UNII: 35SW5USQ3G)  
FD&C red no. 40 (UNII: WZB9127XOA)  
glycerin (UNII: PDC6A3C0OX)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sucrose (UNII: C151H8M554)  
xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
Color ORANGE Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50580-601-08 2 in 1 PACKAGE 01/30/2002
1 NDC:50580-601-04 1 in 1 CARTON
1 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
2 NDC:50580-601-21 1 in 1 CARTON 03/01/2012
2 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
3 NDC:50580-601-22 1 in 1 CARTON 03/01/2012
3 30 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
4 NDC:50580-601-20 1 in 1 CARTON 03/01/2012
4 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
5 NDC:50580-601-25 2 in 1 PACKAGE 07/10/2012
5 NDC:50580-601-20 1 in 1 CARTON
5 120 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020516 09/01/1995
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 6/2019
Document Id: 2b9c3860-c76d-4dfc-bfe8-7b98d013eb73
Set id: f2609308-17bf-4bcb-84b2-d17f3fd35958
Version: 10
Effective Time: 20190614
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division