Leader Ibuprofen Cold Childrens

Leader Ibuprofen Cold Childrens

Leader Ibuprofen Cold Childrens Recall

Get an alert when a recall is issued.

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.

Do not use
  • 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.
Ask a doctor before use if
  • 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
Ask a doctor or pharmacist before use if the child is
  • taking any other drug containing pseudoephedrine or any other nasal decongestant
  • under a doctor’s care for any serious condition
  • taking any other drug
When using this product
  • 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
Stop use and ask a doctor if
  • 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
Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do not use
  • 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.
Ask a doctor before use if
  • 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
Ask a doctor or pharmacist before use if the child is
  • taking any other drug containing pseudoephedrine or any other nasal decongestant
  • under a doctor’s care for any serious condition
  • taking any other drug
Stop use and ask a doctor if
  • 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.

Leader Ibuprofen Cold Childrens Manufacturers


  • Cardinal Health
    Leader Ibuprofen Cold Childrens (Ibuprofen, Pseudoephedrine Hcl) Suspension [Cardinal Health]

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