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leader ibuprofen cold

Cardinal Health

Cardinal Health Ibuprofen Cold Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




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
Dosing Chart
Weight (lb) Age (yrs) Dose (tsp or mL)
under 4 years ask a doctor
36-47 lbs 4 to 5 years 1 tsp or 5 mL
48-95 lbs 6 to 11 years 2 tsp or 10 mL

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

leader ibuprofen cold
Ibuprofen Cold Carton Image 1 Ibuprofen Cold Carton Image 2

leader ibuprofen cold

Ibuprofen, Pseudoephedrine HCl SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-399
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IBUPROFEN IBUPROFEN 100 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
HIGH FRUCTOSE CORN SYRUP
D&C YELLOW NO. 10
FD&C RED NO. 40
GLYCERIN
HYPROMELLOSES
polysorbate 80
water
SODIUM BENZOATE
XANTHAN GUM

Product Characteristics

Color
RED (opaque, viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 120 in 1 BOTTLE
2 NDC:37205-399-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076478 2004-03-25


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