CHILDRENS ADVIL COLD
-
ibuprofen and
pseudoephedrine hydrochloride suspension
Wyeth Consumer Healthcare
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Children’s Advil Cold(ibuprofen and pseudoephedrine HCl)
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOON)
*nonsteroidal anti-inflammatory drug
PURPOSES
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing a NSAID [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 the child has
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- asthma
- not been drinking fluids
- lost a lot of fluid due to vomiting or diarrhea
- high blood pressure
- heart or kidney disease
- thyroid disease
- diabetes
- taken a diuretic
Ask a doctor or pharmacist before use if the child is
- taking any other drug containing a NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- 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 feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding.
- stomach pain or upset gets worse or lasts
- 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
- do not give longer than 10 days, unless directed by a doctor (see WARNINGS)
- 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.
Ibuprofen 100 mg Fever Reducer/Pain Reliever (NSAID) per 5 mL
Pseudoephedrine HCI 15 mg Nasal Decongestant per 5 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 Consumer Healthcare, Madison, NJ 07940
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 |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021373 | 04/18/2002 | |
| Labeler - Wyeth Consumer Healthcare (828831730) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Richmond Division of Wyeth | 829390827 | MANUFACTURE, ANALYSIS | |