Statement from the FDA on Coricidin

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We cannot comment on any one individual’s report of an adverse event from medication. Generally speaking, the FDA takes into account a variety of sources of information to track possible safety issues associated with medical products, including over-the-counter (OTC) drug products. The FDA is not currently aware of data that suggests that OTC products containing dextromethorphan hydrobromide and chlorpheniramine maleate cause psychosis or violent behavior when used as directed, however, we have spoken publicly about certain ingredients found in OTC products having adverse effects when taken at extremely high doses (see additional background). All OTC medicine labels have detailed usage and warning information so consumers can properly choose and use the products. The FDA reminds consumers to use all OTC drug products according to labeled directions in the Drug Facts Label and consult a doctor if cough and cold symptoms persist for more than seven days. 
 
The required labeling for Coricidin HBP Cough and Cold (chlorpheniramine maleate and dextromethorphan hydrobromide) include warnings to not exceed the recommended daily dose of the product, and that abuse of the product can lead to serious injury. The FDA continues to monitor the safety of products containing these ingredients and will take appropriate regulatory action as warranted.  
 
 At supratherapeutic doses (more than 10 to 20 times the recommended adult dose), dextromethorphan can cause psychoactive effects such as hallucinations. An FDA Advisory Committee meeting was held in 1990 and again in 2010 concerning the abuse of dextromethorphan-based cough syrups. Additionally, in 2005, the FDA issued a Talk Paper to notify the public about potential dextromethorphan abuse– you can reference a copy in the FDA’s background materials for the 2010 advisory committee meeting here (see page 5).
 
Regarding warnings for these products:
The required labeling for Coricidin HBP Cough and Cold (which contains chlorpheniramine maleate and dextromethorphan hydrobromide) contains the following warning and dosage information:
 
Warnings:


Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
 
Ask a doctor before use if you have:

  • Glaucoma
  • Trouble urinating due to an enlarged prostate gland 
  • Cough that occurs with excessive phlegm (mucus)
  • A breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

  • Excitability may occur, especially in children 
  • Marked drowsiness may occur
  • Avoid  alcoholic  beverages
  • Alcohol, sedatives, and tranquilizers may increase drowsiness
  • Use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
 
If pregnant or breastfeeding, ask a health professional before use.
 
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Abuse of this product can lead to serious injury.
 
Directions:

  • Do not exceed recommended dose 
  • Adults and children 12 years and over: 1 tablet every 6 hours, not more often than 4 tablets in 24 hours
  • Children under 12 years of age: ask a doctor