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Drugs Approved by the FDA

Drug Name: Children's Motrin Cold

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: McNeil Consumer Products
Approval Status: Approved August 2000
Treatment for: For the temporary relief of common cold symptoms

General Information

Children's Motrin Cold (suspension form) has recently been approved by the FDA for treatment of common cold symptoms, including congestion, aches and pains, fever, headache, and sore throat. This product's active ingredients are ibuprofen and pseudoephedrine HCl, and it will be available for over-the-counter purchase. Children's Motrin is produced by McNeil Consumer Products Company, which is a member of the Johnson & Johnson company group.

Side Effects

Ibuprofen has been known to produce a severe allergic reaction. Some of the possible allergic effects are listed below:

  • Hives
  • Facial swelling
  • Asthma (wheezing)
  • Shock
Other possible side effects of ibuprofen include the following:
  • Muscle cramps, numbness, or tingling
  • Ulcers in the mouth
  • Fluid retention
  • Dry mouth
  • Dizziness or headache
This product should not be used if the child has had a prior allergic reaction to any other pain reliever/ fever reducer.

Mechanism of Action

Ibuprofen acts as an analgesic, and produces anti-pyretic (fever-reducing) and anti-inflammatory effects. It belongs to the nonsteroidal anti-inflammatory (NSAIDs) class of drugs, and acts by reducing levels of prostaglandins in the body.

Pseudoephedrine acts as a decongestant, and is classified as an indirect sympathomimetic amine.

Additional Information

For more information on Children's Motrin, please visit the web site of Motrin IB.

There are additional steps a parent can take to help a child with a cold feel more comfortable:

  • Salt water nose drops and a humidifier can ease congestion
  • Hot liquids or soup can assist in clearing mucus from nasal passages
  • Hot chocolate or tea can soothe a sore throat (from Motrin IB)


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Drug listing last updated on June 20, 2008

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