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Notice on the Change of Safety Content in the Manual of Da Qili SAN
author:Quality Assurance Department
time:2025-11-03
browse:306
<p>Notice on the Change of Safety Content in the Manual of Da Qili SAN</p><p><br/></p><p>To better guide the safe and rational use of drugs in clinical practice, our company, in accordance with the requirements of the announcement (No. 20 of 2023) issued by the National Medical Products Administration on the "Special Provisions on the Administration of the Registration of Traditional Chinese Medicine", has proactively carried out the marketing research on the safety information item of Daqili SAN, revised the contents of the instructions and labels [Adverse Reactions], [Contraindications] and [Precautions], and completed the supplementary application. In order to ensure that patients are fully aware of the revision of the instructions and facilitate their use, our company will inform them of the changes in the form of a notice letter on the company's official website.</p><p><br/></p><p>I. The changes to the instruction manual are as follows:</p><p><br/></p><p>(1) [Adverse Reactions] Changed to "The following adverse reactions may be observed with this product:</p><p><br/></p><p>Skin and subcutaneous tissue: itching, rash, edematous erythema, red rash, red papules, maculopapular rash, blisters, red macules, contact dermatitis and other allergic reactions.</p><p><br/></p><p>Gastrointestinal system: nausea, vomiting, diarrhea, abdominal pain, etc.</p><p><br/></p><p>Others: Dizziness, fever, etc."</p><p><br/></p><p>(2) [Contraindications] changed to "1. Contraindicated for pregnant women." 2. This product is contraindicated for those who are allergic to it or its ingredients.</p><p><br/></p><p>(3) [Precautions] Changed to "1. Take as directed. Do not exceed the dosage or take continuously for a long time."</p><p><br/></p><p>2. Do not apply externally to broken skin areas.</p><p><br/></p><p>3. It is advisable to take it after meals. People with weak spleen and stomach should use it with caution.</p><p><br/></p><p>4. People with allergic constitutions should use with caution.</p><p><br/></p><p>5. Do not use this product if its properties change."</p><p><br/></p><p>The revised content of the instructions is applicable to our company's Da Qili SAN in circulation on the market and will not affect the normal use of the medicine.</p><p><br/></p><p>Iii. If the drug purchased by the patient has the unchanged instructions, the updated instructions can be obtained from the pharmacy or hospital where the purchase was made. If for any reason you are unable to obtain it, please contact our company by the following contact number. Our company can provide the revised paper version of the instruction manual. If you have any other questions, please feel free to call us for communication. (Contact Number: 0592-7266588</p><p><br/></p><p>This is to inform you!</p><p><br/></p><p>Xiamen Chinese Medicine Factory Co., LTD</p><p><br/></p><p>October 13, 2025</p><p><br/></p>
Notice on the Change of Safety Content in the Manual of Da Qili SAN
11-03-2025
Notice on the Change of Safety Content in the Manual of Da Qili SAN
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