The State Drug Administration revised the six-flavored yellow preparation instruction manual

The announcement requires that all licensed holders of all the above-mentioned drugs shall, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, report to the provincial drug regulatory departments for the record by May 2, 2021, in accordance with the revised requirements of the corresponding instructions (see annex).
the contents of the drug shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval contents.
the original drug instructions for medicines produced on the date of filing.
drug market license holder shall replace the factory-issued drug instructions and labels within 9 months of filing.
drug market licensing holders should conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures to do a good job in the publicity and training of drug use and safety issues, and guide physicians and patients to use drugs rationally.
provincial drug supervision and administration department shall urge the drug market license holders of the above-mentioned drugs in the administrative area to do a good job in revising the corresponding instructions and changing the labels and instructions as required, and severely investigate and punish violations of laws and regulations in accordance with the law.
Annex 1 Revision of prescription drug instructions for six-flavored yellow preparations Requirements I, "adverse reactions" item should be added: Monitoring data show that six-flavored yellow preparations have diarrhea, abdominal pain, bloating, nausea, vomiting, gastrointestinal discomfort, loss of appetite, constipation, itching, rash, headache, palpitations, allergies and other adverse reactions reported.
, taboo items should include: "allergic to this product and the ingredients contained in the ban."
, "Precautions" items should include: 1. Avoid spicy, difficult to digest food.
2. Cold patients use it with caution. Annex
Annex 2 Revised requirements for over-the-counter prescription drugs for six-flavored yellow preparations Should include: Monitoring data show that six-flavored yellow preparations have diarrhea, abdominal pain, bloating, nausea, vomiting, gastrointestinal discomfort, loss of appetite, constipation, itching, rash, headache, palpitations, allergies and other adverse reactions reported.
and taboos shall include: those who are allergic to this product and the ingredients contained therein shall be prohibited.
, "Precautions" items should include: 1. Avoid spicy, difficult to digest food.
2. Cold patients use it with caution.
3. When the above adverse reactions occur during taking the drug, the drug should be stopped, if the symptoms do not ease should go to the hospital.
. High blood pressure, heart disease, liver disease, diabetes, kidney disease and other serious cases should be taken under the guidance of a physician.
. In accordance with the usage, children, pregnant women, lactating women should be taken under the guidance of a physician.
6. Take the drug for 2 to 4 weeks without any relief, should go to the hospital.
7. Allergic physiques are used with caution.