FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
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
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.
- 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.
- 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
- 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
- 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
- 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
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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.
- 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
- 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
- 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
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
temporarily relieves these cold, sinus and flu symptoms:
- nasal and sinus congestion
- headache
- stuffy nose
- sore throat
- minor aches and pains
- fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Childrens Advil Cold Manufacturers
-
Pfizer Consumer Healthcare
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