Advil Childrens Cold

Generic Name: ibuprofen, pseudoephedrine hydrochloride
Dosage Form: oral suspension

Children’s Advil Cold
(ibuprofen and pseudoephedrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOON)

Ibuprofen 100 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pseudoephedrine HCl 15 mg

PURPOSES

Fever reducer / Pain reliever

Nasal decongestant

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, 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 a doctor.

Do not use

  • in a child under 2 years of age
  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if

  • stomach bleeding warning applies to your child
  • child has problems or serious side effects from taking pain relievers or fever reducers
  • 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, kidney disease, thyroid disease, diabetes or 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 product that contains pseudoephedrine or any other nasal decongestant
  • taking any other drug

When using this product

  • take 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

  • the 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
  • symptoms continue or get worse
  • fever or pain or nasal congestion gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • the child gets nervous, dizzy, or 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

  • 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.
  • 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.
Weight (lb) Age (yrs) Dose (teaspoons)
under 24 under 2 yrs do not use
24-47 2-5 yrs 1 teaspoon
48-95 6-11 yrs 2 teaspoons

OTHER INFORMATION

  • each teaspoon contains: sodium 3 mg
  • store at room temperature 20-25°C (68-77°F).
  • alcohol free
  • read all warnings and directions before use. Keep carton.

INACTIVE INGREDIENTS

artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, microcrystalline cellulose, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-88-ADVIL or ask your pharmacist, doctor or health care professional.

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

See new warnings information

Children’s Advil Cold

Ibuprofen 100 mg Fever Reducer/Pain Reliever (NSAID) per 5 mL

Pseudoephedrine HCI 15 mg Nasal Decongestant per 5 mL

Cold

IBUPROFEN

Pain Relief

Fever

Sore Throat

PSEUDOEPHEDRINE HCl

Stuffy Nose

Liquid Oral Suspension

Alcohol-Free

Grape Flavor

for ages 2-11 years

4 FL OZ (120 mL)

Important: Read all product information before using. Keep this box for important information. This product is intended for use in children ages 2 years – 11 years.

Wyeth

Wyeth Consumer Healthcare, Madison, NJ 07940 USA

©2010 Wyeth

For most recent product information, visit www.advil.com

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

CHILDRENS ADVIL COLD 
ibuprofen, pseudoephedrine hcl suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0187
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ibuprofen (ibuprofen) ibuprofen 100 mg  in 5 mL
pseudoephedrine hydrochloride (pseudoephedrine ) pseudoephedrine hydrochloride 15 mg  in 5 mL
Product Characteristics
Color PURPLE (translucent purple suspension) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0573-0187-20 1 BOTTLE (BOTTLE) in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021373 04/18/2002
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
Name Address ID/FEI Operations
Richmond Division of Wyeth LLC, a subsidiary of Pfizer Inc. 829390827 MANUFACTURE, ANALYSIS
Revised: 06/2010
 
Pfizer Consumer Healthcare



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