leader ibuprofen cold

Cardinal Health

Cardinal Health Ibuprofen Cold Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL = teaspoonful)
• Purpose
• leader ibuprofen cold 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 cold Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = teaspoonful)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pseudoephedrine HCl 15 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

leader ibuprofen cold Uses

• temporarily relieves these cold, sinus and flu symptoms:
• nasal and sinus congestion
• stuffy nose
• headache
• sore throat
• minor body aches and pains
• 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 and/or nasal decongestant
• right before or after heart surgery
• in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if

• child has problems or serious side effects from taking pain relievers, fever reducers or nasal decongestants
• the stomach bleeding warning applies to your child
• child has a history of stomach problems, such as heartburn
• 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 has thyroid disease
• child has diabetes
• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is

• taking any other drug containing pseudoephedrine or any other nasal decongestant
• under a doctor’s care for any serious condition
• taking any other drug

When using this product

• do not exceed recommended dosage
• 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, pain or nasal congestion gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• the child gets nervous, dizzy or sleepless

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
• 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.
• only use enclosed measuring cup
• if needed, repeat dose every 6 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 cold Other information

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

Inactive ingredients

acesulfame potassium, anhydrous citric acid, D&C yellow #10, FD&C red #40, flavor, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, purified water, sodium benzoate, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

SEE NEW WARNINGS INFORMATION

SEE NEW DOSING DIRECTIONS

Compare to Children's Motrin® Cold active ingredients

For Ages 4-11

CHILDREN'S

Ibuprofen Cold

Ibuprofen/Pseudoephedrine HCl

Oral Suspension

100 mg/15 mg per 5 mL (teaspoonful)

Pain Reliever

Fever Reducer (NSAID)

Nasal Decongestant

Relieves:

Stuffy Nose (Pseudoephedrine HCl)

Sore Throat (Ibuprofen)

Fever (Ibuprofen)

Berry Flavor

Alcohol Free