An article at discusses labeling of cough medicines:

Carbinoxamine containing cough medicines and many other types on the market have been unapproved by the Food and Drug Administration. Some can pose serious health risks, particularly to young children. Because of this, the agency on Thursday launched a campaign to stop these unapproved drug makers.

Carbinoxamine-containing products are the first target of the federal agency’s action under the new guidance, “Marketed Unapproved Drugs–Compliance Policy Guide”. Many others may be dealt with later.

Products with carbinoxamine need FDA approval to be marketed, but numerous products such products, either alone or in combination with other active ingredients, are marketed without FDA approval, the agency states.

The FDA will begin its efforts by watching the use of the antihistamine carbinoxamine, which the agency states can be hurtful to younger children under the age of two.

The federal agency has given cough drop manufacturers using carbinoxamine 30 to 90 days to stop their sale of the unapproved drug.

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