CHILDRENS MOTRIN - ibuprofen suspension 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

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Children's Motrin®

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Ibuprofen 100 mg (NSAID)1

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1

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily:

• relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
• reduces fever

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
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• use only enclosed measuring cup
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day
• replace original bottle cap to maintain child resistance

Dosing Chart

Weight (lb)	Age (yr)	Dose (tsp or mL)
under 2 years		ask a doctor
24-35 lbs	2-3 years	1 tsp or 5 mL
36-47 lbs	4-5 years	1 ½ tsp or 7.5 mL
48-59 lbs	6-8 years	2 tsp or 10 mL
60-71 lbs	9-10 years	2 ½ tsp or 12.5 mL
72-95 lbs	11 years	3 tsp or 15 mL

Other information

• each teaspoon contains: sodium 2 mg
• store between 20-25°C (68-77°F)
• do not use if bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing
• see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

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 50580-601-01

For Ages 2 to 11

Children's
Motrin®

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

Pain Reliever / Fever Reducer

Lasts up to
8 hours

Original
Berry Flavor
Alcohol Free

1 FL OZ (30 mL)

CHILDRENS MOTRIN  ibuprofen   suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 50580-601 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (Ibuprofen) Ibuprofen 100 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength acesulfame potassium   anhydrous citric acid   D&C yellow no. 10   FD&C red no. 40   glycerin   polysorbate 80   water   sodium benzoate   sucrose   xanthan gum

Product Characteristics Color ORANGE Score      Shape Size Flavor BERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50580-601-01 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 1 30 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-601-01) 2 50580-601-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 2 60 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-601-02) 3 50580-601-04 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 3 120 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-601-04) 4 50580-601-08 2 CARTON In 1 PACKAGE contains a CARTON 4 1 BOTTLE In 1 CARTON This package is contained within the PACKAGE (50580-601-08) and contains a BOTTLE, PLASTIC 4 120 mL In 1 BOTTLE, PLASTIC This package is contained within a CARTON and a PACKAGE (50580-601-08) 5 50580-601-50 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 5 120 mL In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50580-601-50)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020516	09/01/1995

Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 04/2011McNeil Consumer Healthcare Div. McNeil-PPC, Inc