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Malaysia National Pharmaceutical Control Bureau : Registered Product Search
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PUTRAJAYA: All cough and cold products must now display warnings to stop them from being used for children aged less than two years.
The Drug Control Authority (DCA) said such products must clearly state in their warnings section on both the labels and package inserts that they should “not be used in children less than two years of age.” It said the affected products were oral liquid preparation containing antihistamines, antitussives and decongestants. “Due to safety and efficacy concerns, the DCA has decided that the use of cough and cold products in children has to be limited and it applies to products which are prescribed by both doctors and pharmacists,” it said in a statement here on Wednesday. The DCA said such medicine could also be harmful for those above two years old if more than the recommended dosage was given or they were given the products too often. “It is also harmful if more than one product containing the same active ingredient is used,” it said. It said that until the re-labelling by manufacturers was completed, parents and caregivers were advised not to use cough and cold products containing these ingredients in children below two years old. “For those aged between two to six, these products must be used with caution and on doctors’ and pharmacists’ advice,” it said. Source from: The Star |
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