While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well.
The labels will also warn adult users about the risks of addiction, overdose and death. Notably, the FDA advisory committees that have been responsible for assessing the suitability of utilizing opioids as treatment options for coughs and colds in pediatric populations have focused on two age groups: those 6 to 12, and those 12 to 18. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits", the FDA said in announcing the new labeling.
But health officials say that shouldn't be a problem as most coughs don't need any treatment.
According to a new safety communication, the Food and Drug Administration (FDA) is requiring that changes be made to the labeling of prescription cough and cold medicines containing codeine and hydrocodone.
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The move is in response to the opioid addiction epidemic. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products", he said.
The FDA will also carry bigger warning about their dangers to adults, NBC News reported. Common side effects of opioids include headache, dizziness and vomiting.
The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.
It's always important to read medicine labeling, too - even if it's not obtained by prescription.