Pediacare Infants

Pediacare Infants

Pediacare Infants 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
  • shock
  • rash
  • asthma (wheezing)
  • skin reddening
  • 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 the 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
  • right before or after heart surgery
Ask a doctor before use if
  • 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 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 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
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • child experiences any of the following sighs 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 or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • 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 (1-800-222-1222).

Do not use
  • if the child has ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Ask a doctor before use if
  • 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 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 drug
Stop use and ask a doctor if
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • child experiences any of the following sighs 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 or pain gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • 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:

  • reduces fever
  • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

History

There is currently no drug history available for this drug.

Other Information

There are no additional details available for this product.

Pediacare Infants Manufacturers


  • Medtech Products Inc.
    Pediacare Infants (Ibuprofen) Liquid [Medtech Products Inc.]

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