The State Food and Drug Administration revised the instructions for 4 kinds of medicines including cold-removing preparations

On July 7, the State Food and Drug Administration issued an announcement (No.

According to the announcement, according to the results of the adverse drug reaction evaluation, in order to further protect the safety of the public use of drugs, the National Medical Products Administration has decided to uniformly revise the four instructions [adverse reactions], [taboos] and [precautions] items including cold-removing preparations

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.

Attachment 1: Requirements for the revision of the instructions for cold-removing cold preparations

1.

Adverse Reaction Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, diarrhea, abdominal pain, bloating, abdominal discomfort, dry mouth, rash, itching, palpitations, allergic reactions, breathing difficulties

2.

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

3.

1.

2.

3.

4.
Symptoms do not improve after 3 days of taking the medicine, or fever and cough aggravate, and other serious symptoms such as chest tightness, palpitations, etc.
should go to the hospital
.

5.
Patients with fever and body temperature exceeding 38.
5℃ should go to the hospital for treatment
.

6.
When adverse reactions occur when using this product, the drug should be discontinued and seek medical attention in time
.

Attachment 2: Requirements for the revision of the instructions for Rupi Sanjie preparations

1.
[Adverse Reaction] item should be added:

Monitoring data shows that the product can see the following adverse reactions: nausea, dry mouth, vomiting, constipation, abdominal pain, diarrhea, rash, itching, dizziness, headache, palpitations, allergic reactions, etc.
, there are reports of abnormal liver function biochemical indicators
.

2.
[Taboo] item should be added:

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

3.
[Precautions] item should be added:

Pay attention to monitoring liver function during medication.
If there are clinical manifestations such as abnormal liver function biochemical indicators, fatigue, anorexia, yellow skin, yellow urine, etc.
, the drug should be stopped immediately and seek medical attention
.

Attachment 3: Revision requirements for the instructions for Xiaoer Resuqing oral preparations (prescription drugs)

1.
[Adverse Reaction] item should be added:

Monitoring data show that thermal rate in children clear oral formulations have the following side effects: nausea, vomiting, abdominal pain, diarrhea, itching, rashes and so on
.

2.
[Taboo] item should be added:

1.
People who are allergic to this product and its ingredients are forbidden
.

2.
It is forbidden for people with cold and cold
.

3.
[Precautions] item should be added:

Strictly follow the usage and dosage.
This product should not be taken for a long time
.

Attachment 4: Revision requirements for the instructions of Xiaoer Resuqing oral preparations (over-the-counter drugs)

1.
[Adverse Reaction] item should be added:

Monitoring data showed that there were reports of adverse reactions such as nausea, vomiting, abdominal pain, diarrhea, pruritus, and skin rash in the Xiaoer Resuqing oral preparation
.

2.
[Taboo] item should be added:

1.
People who are allergic to this product and its ingredients are forbidden
.

2.
It is forbidden for people with cold and cold
.

3.
[Precautions] item should be added:

1.
Infants should be taken under the guidance of a physician
.

2.
Children with chronic diseases such as hypertension, heart disease, liver disease, diabetes, and kidney disease should be taken under the guidance of a physician
.

3.
Those who are prone to diarrhea due to spleen deficiency should take it under the guidance of a physician
.

4.
Patients with fever and body temperature exceeding 38.
5°C should go to the hospital for treatment
.

5.
Strictly follow the usage and dosage.
This product should not be taken for a long time
.

6.
If the condition is severe or the effect is not obvious after taking the medicine 24 hours later, you should go to the hospital for treatment in time
.

7.
People who are allergic to this product and its ingredients are prohibited, and those who are allergic to use it with caution
.

Attachment 5: Requirements for revision of the instructions for pharyngitis tablets (capsules)

1.
[Adverse reactions] items should include:

Adverse Reaction Monitoring data show that the product can see the following adverse reactions: nausea, vomiting, abdominal pain, diarrhea, bloating, abdominal discomfort, rash, itching, flushing, dizziness, headache, palpitations, drowsiness, allergic reactions
.

2.
[Taboo] item should be added:

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

3.
[Precautions] items should include:

1.
This product is recommended to be taken after meals
.

2.
Use with caution for those with weak spleen and stomach
.

3.
When adverse reactions occur when using this product, the drug should be discontinued and seek medical attention in time
.