The State Food and Drug Administration publishes and revises the over-the-counter drug manual model of Pudilan Xiaoyan tablets (capsules)

According to the monitoring and evaluation results, in order to further ensure the safety of public drug use, the State Drug Administration decided to revise the non prescription drug manual model of Pudilan Xiaoyan tablet (capsule) The relevant matters are hereby announced as follows: 1 The manufacturer of Pudilan Xiaoyan tablet (capsule) over-the-counter drugs shall, in accordance with the measures for the administration of drug registration and other relevant provisions, put forward the supplementary application for amending the manual in accordance with the model manual of Pudilan Xiaoyan tablet (capsule) over-the-counter drugs (see Annex 1 and Annex 2), and report to the provincial drug regulatory authority for the record before December 31, 2018 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents For drugs manufactured from the date of filing of the supplementary application, the original drug instructions shall not be used any more The over-the-counter drug manufacturers of Pudilan Xiaoyan tablets (capsules) shall take effective measures to do a good job of publicity and training on the use and safety of Pudilan Xiaoyan tablets (capsules) in a timely manner, and guide doctors, pharmacists and patients in the rational use of drugs 2、 Clinicians and pharmacists should carefully read the revised contents of the drug Manual of Pudilan Xiaoyan tablets (capsules), and make full benefit / risk analysis or guide drug use according to the newly revised manual when selecting or guiding drug use 3、 Patients should carefully read the over-the-counter drug instructions of Pudilan Xiaoyan tablets (capsules) before taking medicine 4、 Each provincial drug regulatory department shall urge the relevant drug manufacturers in the administrative region to do a good job in the revision, labeling and replacement of the OTC drug instructions of Pudilan Xiaoyan tablets (capsules) It is hereby announced Annex: 1 Model of over-the-counter drug Manual of Pudilan Xiaoyan tablet 2 Model of over-the-counter drug Manual of Pudilan Xiaoyan capsule SFDA November 1, 2018 SFDA Announcement No 82, 2018 annex 1.doc SFDA Announcement No 82, 2018 annex 2.doc Annex 1 model of over-the-counter drug Manual of Pudilan Xiaoyan tablet Please read the manual carefully and use it according to the instructions or purchase and use it under the guidance of pharmacists General name: Chinese Pinyin of Pudilan Xiaoyan tablet: [ingredients] [properties] [function indications] heat clearing and detoxification, anti-inflammatory and swelling reducing For boils, pharyngitis, tonsillitis [Specification] each tablet weighs 0.3g [usage and dosage] orally 5-8 tablets at a time, 4 times a day [adverse reactions] the preparation has the following adverse reactions: nausea, vomiting, abdominal distention, abdominal pain, diarrhea, dizziness, fatigue, etc.; rash, pruritus and other allergic reactions [contraindications] it is forbidden to use this product or its ingredients [precautions] 1 Avoid spicy and irritant food 2 Warm drugs should not be taken at the same time 3 Patients with abdominal pain, fever, diarrhea and other spleen and stomach deficiency cold should be used with caution 4 Pregnant women should use it with caution Children, lactating women, the elderly and the weak should use it under the guidance of doctors 5 Patients with chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should be used under the guidance of doctors 6 Patients with severe sores and boils or local softening and purulence; patients with tonsillar purulence and general high fever should go to the hospital for treatment 7 If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital 8 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution 9 It is forbidden to use this product when its properties change 10 Children must be used under adult supervision 11 Please keep this product out of the reach of children 12 If you are using other drugs, please consult a doctor or pharmacist before using this product [drug interaction] drug interaction may occur if it is used with other drugs at the same time Please consult your doctor or pharmacist for details [storage], [packaging], [expiry date], [executive standard], [approval document No.] [revision date of instruction manual], [production enterprise] Enterprise Name: production address: Postal Code: telephone number: Fax Number: website: if you have any questions, you can contact the production enterprise for the instruction of Pudilan antiphlogistic tablets Please read the manual carefully and use it according to the instructions or purchase and use [drug name] under the guidance of pharmacist General name: Pudilan Xiaoyan tablet Chinese Pinyin: [ingredients], [properties], [function indications] heat clearing and detoxification, anti inflammation and swelling elimination For boils, pharyngitis, tonsillitis [Specification] each tablet weighs 0.6g [usage and dosage] orally Three to four tablets at a time, four times a day [adverse reactions] the preparation has the following adverse reactions: nausea, vomiting, abdominal distention, abdominal pain, diarrhea, dizziness, fatigue, etc.; rash, pruritus and other allergic reactions [contraindications] it is forbidden to use this product or its ingredients [precautions] 1 Avoid spicy and irritant food 2 Warm drugs should not be taken at the same time 3 Patients with abdominal pain, fever, diarrhea and other spleen and stomach deficiency cold should be used with caution 4 Pregnant women should use it with caution Children, lactating women, the elderly and the weak should use it under the guidance of doctors 5 Patients with chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should be used under the guidance of doctors 6 Patients with severe sores and boils or local softening and purulence; patients with tonsillar purulence and general high fever should go to the hospital for treatment 7 If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital 8 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution 9 It is forbidden to use this product when its properties change 10 Children must be used under adult supervision 11 Please keep this product out of the reach of children 12 If you are using other drugs, please consult a doctor or pharmacist before using this product [drug interaction] drug interaction may occur if it is used with other drugs at the same time Please consult your doctor or pharmacist for details [storage], [packaging], [expiry date], [executive standard], [approval document No.] [revision date of instruction manual], [production enterprise] Enterprise Name: production address: Postal Code: telephone number: Fax Number: website: if you have any questions, you can contact the production enterprise for the instruction of Pudilan antiphlogistic tablets Please read the manual carefully and use it according to the instructions or purchase and use [drug name] under the guidance of pharmacist General name: Pudilan Xiaoyan tablet Chinese Pinyin: [ingredients], [properties], [function indications] heat clearing and detoxification, anti inflammation and swelling elimination For boils, pharyngitis, tonsillitis [Specification] each tablet weighs 0.73g [usage and dosage] orally Two to three tablets at a time, four times a day, with children taking less [adverse reactions] the preparation has the following adverse reactions: nausea, vomiting, abdominal distention, abdominal pain, diarrhea, dizziness, fatigue, etc.; rash, pruritus and other allergic reactions [contraindications] it is forbidden to use this product or its ingredients [precautions] 1 Avoid spicy and irritant food 2 Warm drugs should not be taken at the same time 3 Patients with abdominal pain, fever, diarrhea and other spleen and stomach deficiency cold should be used with caution 4 Pregnant women should use it with caution Children, lactating women, the elderly and the weak should use it under the guidance of doctors 5 Patients with chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should be used under the guidance of doctors 6 Patients with severe sores and boils or local softening and purulence; patients with tonsillar purulence and general high fever should go to the hospital for treatment 7 If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital 8 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution 9 It is forbidden to use this product when its properties change 10 Children must be used under adult supervision 11 Please keep this product out of the reach of children 12 If you are using other drugs, please consult a doctor or pharmacist before using this product [drug interaction] drug interaction may occur if it is used with other drugs at the same time Please consult your doctor or pharmacist for details [storage], [packaging], [expiry date], [executive standard], [approval document No.] [revision date of instruction manual], [production enterprise] Enterprise Name: production address: Postal Code: telephone number: Fax Number: website: if you have any questions, you can contact the production enterprise for the instruction of Pudilan antiphlogistic tablets Please read the manual carefully and use it according to the instructions or purchase and use [drug name] under the guidance of pharmacist General name: Pudilan Xiaoyan tablet Chinese Pinyin: [ingredients], [properties], [function indications] heat clearing and detoxification, anti inflammation and swelling elimination For boils, pharyngitis, tonsillitis [Specification] each tablet weighs 0.31g [usage and dosage] orally 5-8 tablets at a time, 4 times a day, with children taking less [adverse reactions] the preparation has the following adverse reactions: nausea, vomiting, abdominal distention, abdominal pain, diarrhea, dizziness, fatigue, etc.; rash, pruritus and other allergic reactions [contraindications] it is forbidden to use this product or its ingredients [precautions] 1 Avoid spicy and irritant food 2 Warm drugs should not be taken at the same time 3 Patients with abdominal pain, fever, diarrhea and other spleen and stomach deficiency cold should be used with caution 4 Pregnant women should use it with caution Children, lactating women, the elderly and the weak should use it under the guidance of doctors 5 Patients with chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should be used under the guidance of doctors 6 Patients with severe sores and boils or local softening and purulence; patients with tonsillar purulence and general high fever should go to the hospital for treatment 7 If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital 8 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution 9 It is forbidden to use this product when its properties change 10 Children must be used under adult supervision 11 Please keep this product out of the reach of children 12 If you are using other drugs, please consult a doctor or pharmacist before using this product [drug interaction] drug interaction may occur if it is used with other drugs at the same time Please consult your doctor or pharmacist for details [storage], [packaging], [expiry date], [executive standard], [approval document No.] [revision date of instruction manual], [manufacturer] company name: production address: Postal Code: telephone number: Fax Number: website: if you have any questions, please contact the manufacturer, Appendix 2: instruction manual of Pudilan Xiaoyan capsule, model of non prescription medicine instruction manual of Pudilan Xiaoyan capsule Please read the manual carefully and use it according to the instructions or purchase and use [drug name] under the guidance of pharmacist General name: Pudilan Xiaoyan capsule Chinese Pinyin: [ingredients], [properties], [function indications] heat clearing and detoxification, anti inflammation and swelling elimination For boils, pharyngitis, tonsillitis [Specification] 0.4g per capsule [usage and dosage] oral Three to five capsules at a time, four times a day, with a reduction in the number of children [adverse reactions] the preparation has the following adverse reactions: nausea, vomiting, abdominal distention, abdominal pain, diarrhea, dizziness, fatigue, etc.; rash, pruritus and other allergic reactions [contraindications] it is forbidden to use this product or its ingredients [precautions] 1 Avoid spicy and irritant food 2 Warm drugs should not be taken at the same time 3 Patients with abdominal pain, fever, diarrhea and other spleen and stomach deficiency cold should be used with caution 4 Pregnant women should use it with caution Children, lactating women, the elderly and the weak should use it under the guidance of doctors 5 Patients with chronic diseases such as hypertension, heart disease, liver disease, diabetes and kidney disease should be used under the guidance of doctors 6 Patients with severe sores and boils or local softening and purulence; patients with tonsillar purulence and general high fever should go to the hospital for treatment 7 If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital 8 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution 9 It is forbidden to use this product when its properties change 10 Children must be used under adult supervision 11 Please keep this product out of the reach of children 12 If you are using other drugs, please consult a doctor or pharmacist before using this product [drug interactions] such as with other drugs