MOTRIN  JUNIOR STRENGTH- ibuprofen tablet, film coated 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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Motrin®
Junior Strength

Drug Facts

Active ingredient (in each caplet)

Ibuprofen 100 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

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 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, or kidney disease
  • 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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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
  • 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
  • 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)Caplets
under 48under 6ask a doctor
48-596-82
60-719-102 ½
72-95113

Other information

  • store between 20-25°C (68-77°F)
  • do not use if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
  • see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, shellac, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments?

Call 1-877-895-3665: weekdays 8:00 AM to 8:00 PM EST

PRINCIPAL DISPLAY PANEL

See New Warnings Information

NDC 50580-498-24

Motrin®

Junior Strength
For Ages
6 to 11

Lasts up to
8 hours

contains
Ibuprofen Tablets (NSAID), 100 mg

Pain Reliever / Fever Reducer

24 Caplets*

*Capsule-Shaped Tablets

Principal Display Panel
MOTRIN   JUNIOR STRENGTH
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-498
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ibuprofen (Ibuprofen) Ibuprofen100 mg
Inactive Ingredients
Ingredient NameStrength
acesulfame potassium 
carnauba wax 
silicon dioxide 
starch, corn 
D&C yellow NO. 10 
aluminum oxide 
FD&C yellow NO. 6 
hypromelloses 
cellulose, microcrystalline 
polydextrose 
polyethylene glycols 
shellac 
sodium starch glycolate type a potato 
titanium dioxide 
triacetin 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize11mm
FlavorImprint Code M;100
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-498-241 in 1 CARTON
124 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02060210/01/199810/25/2013
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 11/2013
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc