Children's Advil Cold Suspension (Wyeth)

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Active Ingredients:

(in each 5mL teaspoon)

Ibuprofen 100 mg

Pseudoephedrine HCl 15 mg

Uses:    temporarily relieves these cold, sinus and flu symptoms:

• nasal and sinus congestion · headache
• stuffy nose · sore throat
• minor aches and pains · fever

Warnings:

Allergy alert:    Ibuprofen may cause a severe allergic reaction which may include: · hives · facial swelling · asthma (wheezing) · shock

Stomach bleeding warning:    Taking more than recommended may cause stomach bleeding

Sore throat warning:    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor right away. Do not use more than 2 days or give to children under 3 years of age unless directed by a doctor.

Do not use:

• if the child has ever had an allergic reaction to any pain reliever, fever reducer or nasal decongestant
• 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 the child has

• not been drinking fluids
• lost a lot of fluid due to continued vomiting or diarrhea
• problems or serious side effects from taking any pain reliever, fever reducer or nasal decongestant
• stomach problems that last or come back, such as heartburn, upset stomach or pain · diabetes
• high blood pressure, heart or kidney disease or is taking a diuretic
• thyroid disease · ulcers · bleeding problems

Ask a doctor or pharmacist before use if the child is

• under a doctor's care for any serious condition
• taking any other drug
• taking any other product that contains ibuprofen or any other pain reliever/fever reducer
• taking any other product that contains pseudoephedrine or any other nasal decongestant
• taking a prescription product for anticoagulation (blood thinning)

When using this product

• do not use more than directed
• give with food or milk if stomach upset occurs

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• the child does not get any relief within first day (24 hours) of treatment
• fever or pain or nasal congestion gets worse or lasts for more than 3 days
• stomach pain or upset gets worse or lasts
• symptoms continue or get worse
• redness or swelling is present in the painful area
• the child gets nervous, dizzy, sleepless or sleepy
• 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:

• 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.
• if needed, repeat dose every 6 hours
• do not use more than 4 times a day
• replace original bottle cap to maintain child resistance
• measure only with dosing cup provided. Dosing cup to be used with Children's Advil Cold Suspension only. Do not use with other products. Dose lines account for product remaining in cup due to thickness of suspension.

Other Information:

• each teaspoon contains:   sodium 3 mg
• store at room temperature 20-25°C (68-77°F)
• alcohol free

Inactive Ingredients:    acetic acid, artificial flavor, butylated hydroxy toluene, carboxymethylcellulose sodium, citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

How Supplied:    Bottles of 4 fl. oz. in grape flavor.

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