Leader Ibuprofen

Cardinal Health

Cardinal Health Children's Ibuprofen Oral Suspension 100 mg per 5 mL Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL = 1 teaspoonful)
• Purposes
• Leader Ibuprofen Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if the child is
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Leader Ibuprofen Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Leader Ibuprofen 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

• •give 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. 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
• •wash dosage cup after each use

Leader Ibuprofen Other information

• •each teaspoon contains: sodium 2 mg
• •do not use if printed neckband is broken or missing
• •store at 20-25°C (68-77°F)
• •do not freeze
• •see bottom panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C red #40, glycerin, high fructose corn syrup, hypromellose, natural and artificial bubblegum flavors, polysorbate 80, purified water, sodium benzoate, sorbitol solution, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Children’s Motrin® active ingredient

For Ages 2 to 11

CHILDREN'S Ibuprofen Oral Suspension

100 mg per 5 mL (teaspoonful)

Pain Reliever/Fever Reducer (NSAID)

Lasts up to 8 hours

Bubble Gum Flavor

Alcohol Free