Recently, in order to further protect the safety of public medication, the National Medical Products Administration has decided to treat

paracetamol and paracetamol oral solution, paracetamol and paracetamol syrup, pediatric paracetamol granules, paracetamol pseudoephedrine chewable tablets, pediatric compound paracetamol tablets, Pediatric Amino Kahuangmin Granules, Amino Jinhuang Min Granules, Amino Ka Yumin Solution, Children's Compound Paracetamol and Renin Tablets, Amino Kahuang Min Oral Solution, Paracetamol and Pseudoephedrine Dispersible Tablets (Ⅲ), Pediatric Paracetamol and Namin Tablets The

drug inserts of 14 varieties

, including Xiaoer's Paracetamol Huang Namin Tablets and Pediatric Paracetamol Huang Namin Granules

, will be revised:

　　1.

Add a warning: "Parents or guardians are not recommended to use this product on their own for infants under 2 years old, and should be used under the guidance of a physician or pharmacist."

　　2. Notes for modification and addition:

　　Add

"Parents or guardians are not recommended to use this product on their own for infants under 2 years old, and should be used under the guidance of a physician or pharmacist."

　　Add

"Should strictly follow the usage and dosage of the drug instructions to avoid overdose."

　　Change

"cannot take other anti-cold medicines with similar ingredients to this product at the same time" to "should avoid the combined use of anti-cold medicines containing the same or similar active ingredients."

　　The marketing authorization holders of the above-mentioned drugs shall, in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, submit a supplementary application for the revision of the label in accordance with the requirements of the revision of the label, and submit it to the Drug Evaluation Center of the National Medical Products Administration before July 21, 2021 or Provincial drug supervision and administration department for the record.

　　If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content.

Drugs produced on the date of filing shall not continue to use the original drug instructions.

The holder of the drug marketing authorization shall replace all the drug insert sheets and labels that have been shipped out of the factory within 9 months after filing.

　　The drug marketing license holder shall take effective measures to conduct publicity and training on the use and safety issues, and immediately notify the drug dealer and user unit in an appropriate manner to instruct physicians and pharmacists to use the drugs rationally.

　　Clinicians and pharmacists should carefully read the revised contents of the drug inserts, and when choosing medications, they should conduct adequate benefit and risk analysis based on the newly revised inserts.

　　Patients and their guardians should read the instructions carefully before taking the medicine, and strictly follow the instructions and the doctor's prescription for medication.

　　The provincial drug supervision and management department shall urge the holders of the drug marketing authorization of this product in the administrative area to do the revision of the corresponding instructions and the replacement of the label and the instructions as required, and strictly investigate and deal with violations of laws and regulations in accordance with the law.

(CCTV reporter Yu Jingying)

　　(Edit Zhao Hanqing)