China Revises Cold Medicine Labels, Adds Driving Ban; 999 Brand Sales Top RMB 2 Billion

China's National Medical Products Administration issued a notice announcing unified revisions to the package inserts of cold-ling oral preparations, based on adverse drug reaction assessment results. The revisions enhance warnings, contraindications, adverse reactions, and precautions. The updated labeling emphasizes that patients must not drive motor vehicles, operate boats, work at heights, engage in mechanical operations, or operate precision instruments while taking the medication.

All marketing authorization holders of cold-ling oral preparations must file the revised inserts with provincial drug regulatory authorities by October 15, 2026. Products manufactured after the filing date may no longer use the original package inserts. Within nine months of completing the filing, companies must replace the inserts and labels of already-marketed products or inform patients of the updated information through other appropriate means. Marketing authorization holders are also required to conduct research on the mechanisms of newly identified adverse reactions, strengthen safety publicity and training, and guide rational drug use.

The adverse reactions section has been significantly expanded to cover skin, neurological, digestive, hepatorenal, and urinary system reactions.

A manager of a chain pharmacy said the new standardized inserts clearly specify warnings such as the driving ban, allowing staff to provide risk alerts to purchasers based on official content, effectively reducing the likelihood of customer complaints and anti-counterfeiting claims. In routine sales scenarios, general risk warnings are delivered through in-store posters, electronic screens, and text on drug packaging. Huang Xiuxiang, former secretary-general of the Hunan Pharmaceutical Circulation Industry Association, noted that current Good Supply Practice standards do not mandate that staff verbally remind every customer individually, but pharmacies must provide compliant new inserts and are prohibited from selling products that have not undergone label and insert updates. Licensed pharmacists should proactively inquire about medical history and occupation when serving elderly patients, severely ill patients, and professional drivers, and provide medication guidance.

A judgment from the People's Court of Renshou County, Sichuan Province, in a right-to-life dispute case showed that a victim surnamed Jin suffered severe traumatic brain injury in a traffic accident. His family purchased medication from a pharmacy without mentioning the severe medical history, and the pharmacy's licensed pharmacist did not proactively inquire. The pharmacy also improperly repackaged four drugs into unlabeled bags without providing original packaging or inserts. Judicial appraisal determined that Jin's death was consistent with severe traumatic brain injury from the traffic accident, complicated by pulmonary infection and chlorpheniramine poisoning. The court ruled that the pharmacy bore 40% liability for multiple sales violations and ordered it to pay RMB 87,000 in compensation.

Huang Xiuxiang pointed out that in daily practice, consumers often do not know what medication they have taken, and liability determination centers on package inserts. Pharmacy fault mainly arises when they fail to provide compliant products or when major omissions cause harm. Under the new rules, pharmacies must ensure they provide updated inserts, and distribution channels must not sell products that have not been updated. Hospital pharmacies and retail pharmacies can strengthen training, but fully mandating verbal reminders for every transaction is difficult; auxiliary prompts such as labels, in-store displays, and electronic screens are more practical.