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    Home > Medical News > Latest Medical News > The State Food and Drug Administration revised the instructions for 10 dosage forms including antiviral syrup and capsules

    The State Food and Drug Administration revised the instructions for 10 dosage forms including antiviral syrup and capsules

    • Last Update: 2021-10-20
    • Source: Internet
    • Author: User
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    On October 12, according to the results of the adverse drug reaction assessment, in order to further protect the safety of public medication, the National Medical Products Administration decided to fight virus syrup, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewing The instructions for tablets, oral liquids, and granules will be revised in a unified way


    details as follows:

    details as follows:

    1.


    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


    2.


    3.


    4.


    5.


    Hereby announce


    attachment1

    attachment1

    Revision requirements for prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    Revision requirements for prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    1.


    Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, diarrhea, abdominal pain, bloating, abdominal discomfort, rash, itching, and allergic reactions


    2.


    People who are allergic to this product and its ingredients are prohibited


    3.


    1.


    2.


    3.


    Annex 2

    Annex 2

    Revision requirements for non-prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    Revision requirements for non-prescription drug instructions for antiviral syrups, capsules, soft capsules, pills (concentrated pills), dripping pills, tablets, effervescent tablets, chewable tablets, oral liquids, and granules

    1.
    [Adverse reactions] items should include:

    Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, diarrhea, abdominal pain, bloating, abdominal discomfort, rash, itching, and allergic reactions
    .

    2.
    [Taboo] item should be added:

    People who are allergic to this product and its ingredients are prohibited
    .

    3.
    [Precautions] item should be added:

    1.
    Use it with caution if you have diarrhea if you are chronically ill and physically weak
    .

    2.
    This product contains turmeric, it is not suitable to be used together with cloves and mother cloves
    .

    4.
    [Precautions] item should be changed:

    "Patients with severe chronic diseases such as hypertension, heart disease, liver disease, diabetes, kidney disease should be taken under the guidance of a physician
    .
    " Should be revised to: "Patients with hypertension, heart disease, liver disease, diabetes, kidney disease, etc.
    should be taken under the guidance of a physician
    .
    "

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