FDA records indicate that there are no current recalls for this drug.
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Ibuprofen Cold Relief Childrens Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
- 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.
- 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
- taking any other drug containing pseudoephedrine or any other nasal decongestant
- under a doctor’s care for any serious condition
- taking any other drug
- 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
- 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
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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.
- 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
- taking any other drug containing pseudoephedrine or any other nasal decongestant
- under a doctor’s care for any serious condition
- taking any other drug
- 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
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
- stuffy nose
- headache
- sore throat
- minor body 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
Ibuprofen Cold Relief Childrens Manufacturers
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Cvs Pharmacy
Ibuprofen Cold Relief Childrens | Cvs Pharmacy
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
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