LEADER CHILDRENS IBUPROFEN - ibuprofen suspension 
Cardinal Health

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Cardinal Health Children's Ibuprofen Oral Suspension Drug Facts

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.

The chance is higher if the child:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing an NSAID (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 the child has

• problems or serious side effects from taking pain relievers or fever reducers
• stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
• ulcers
• bleeding problems
• not been drinking fluids
• lost a lot of fluid due to vomiting or diarrhea
• high blood pressure
• heart or kidney disease
• taken a diuretic

Ask a doctor or pharmacist before use if the child is

• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• under a doctor’s care for any serious condition
• taking any other drug

When using this product

• give with food or milk if stomach upset occurs
• long term continuous use may increase the risk of heart attack or stroke

Stop use and ask a doctor if

• the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
• stomach pain or upset gets worse or lasts
• 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.

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• do not give longer than 10 days, unless directed by a doctor (see Warnings)
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• use only with 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
• wash dosage cup after each use

Dosing Chart
Weight (lb)	Age(yrs)	Dose (teaspoonful 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

• do not use if printed neckband is broken or missing
• store at 20-25°C (68-77°F)
• see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, butylparaben, corn syrup, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Motrin® active ingredient

For Ages 2 - 11

Children’s

Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever

Fever Reducer (NSAID)

Lasts Up to 8 Hours

Grape Flavor

Alcohol Free

LEADER CHILDRENS IBUPROFEN  ibuprofen   suspension

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 37205-283 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 No Inactive Ingredients Found

Product Characteristics Color PURPLE Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 37205-283-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (37205-283-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074937	04/25/2002

Labeler - Cardinal Health (097537435)

Revised: 07/2009Cardinal Health