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

On February 18, the State Drug Administration issued a notice announcing that it had decided to revise the instructions (adverse reactions) and "precautions" for six-flavored yellow preparations (including pills, capsules, tablets, enseging agents, omelettes, granules). 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 department for the record by May 2, 2021, in accordance with the revised requirements of the corresponding instructions (see annex).
of the amendment relates to the drug label, it shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval content.
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 shall 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 strictly investigate and punish violations of laws and regulations in accordance with the law.
Annex 1 Six-flavored yellow preparation prescription drug instructions revised requirements I, "adverse reactions" item should be increased: monitoring data show that hexa-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 disabled.
, "Precautions" items should include: 1. Avoid spicy, difficult to digest food.
2. Cold patients use it with caution.
Annex 26 yellow preparation over-the-counter drug instructions revised requirements 1, "adverse reactions" items should include: monitoring data show that the six-flavored yellow preparation has 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 disabled.
, "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 are not alleviated should go to the hospital.
. People with severe blood pressure, heart disease, liver disease, diabetes, kidney disease, etc. should take it under the guidance of a physician.
. Children, pregnant women and lactating women should take them under the guidance of a physician in accordance with the usage.
6. Take the drug for 2 to 4 weeks symptoms are not alleviated, should go to the hospital.
7. Allergic physiques should be used with caution.