The State Food and Drug Administration revises the drug insert of the children's phlegm-relieving and cough-relieving preparations

The State Food and Drug Administration issued an announcement stating that, based on the results of the adverse drug reaction assessment, in order to further ensure the safety of public medication, it has decided to revise the instruction manual of the Pediatric Huatan and Antitussive Preparations.
item
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1.
The marketing authorization holders of the above-mentioned drugs should submit a supplementary application for the revision of the instructions in accordance with the relevant regulations such as the "Administrative Measures for Drug Registration" and the requirements for the revision of the instructions (see attachment), and report to the provincial drug administration before June 17, 2022.
Management records
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If the revised content involves the drug label, it shall be revised together; the instructions and other contents of the label shall be consistent with the original approved content
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Drugs produced from the date of filing shall not continue to use the original drug inserts
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The drug marketing authorization holder shall replace the package insert and label of the drug that has already left the factory within 9 months after filing
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2.
The drug marketing license holder shall conduct in-depth research on the occurrence mechanism of newly added adverse reactions, take effective measures to do a good job in publicity and training on drug use and safety issues, and guide physicians, pharmacists and patients to use drugs rationally
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3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug insert sheets, and should conduct adequate benefit/risk analysis according to the newly revised insert sheets when choosing medication
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4.
Patients should read the instructions carefully before taking medication, and those who use prescription drugs should strictly follow the doctor's instructions
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5.
The provincial drug regulatory authorities shall promptly urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job of revising the corresponding instructions and replacing the labels and instructions as required, and strictly investigate and punish violations of laws and regulations in accordance with the law
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Attachment: 1.
Revision requirements for the instructions of non-prescription drugs for children's anti-phlegm and anti-cough preparations 1.
The item [adverse reactions] should include: Monitoring data show that children's anti-phlegm and anti-cough preparations have vomiting, nausea, diarrhea, abdominal pain, rash, itching, sweating, dizziness, Headache, allergic reaction and other adverse reaction reports
.
2.
[Contraindications] items should include: Those who are allergic to this product and its ingredients are prohibited
.
3.
[Notes] items should include: 1.
Avoid spicy, cold and greasy food
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2.
Babies should be used under the guidance of a physician
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3.
Patients with liver disease, kidney disease and diabetes should take it under the guidance of a physician
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4.
Use with caution in children with heart disease
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People with spleen deficiency and easy diarrhea should take it with caution
.
5.
This product contains ephedrine hydrochloride
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Athletes should use it with caution; patients with glaucoma should use it under the guidance of a physician; if there are symptoms such as dizziness, headache, tachycardia, and excessive sweating after taking it, consult a physician or pharmacist
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6.
This product is a Chinese and Western medicine compound preparation for expectorating phlegm and relieving cough.
It is suitable for mild cough due to lung heat in children
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7.
Take it strictly in accordance with the usage and dosage, and do not overdose
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8.
This product should not be taken for a long time.
If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital for treatment
.
9.
People with allergies should use with caution
.
10.
It is forbidden to use when the properties of this product are changed
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11.
Children must be used under adult supervision
.
12.
Please keep this product out of the reach of children
.
13.
If you are using other medicines, please consult your physician or pharmacist before using this product
.
2.
Requirements for the revision of the prescription drug instructions of the paediatric anti-phlegm and anti-cough preparations 1.
The item [adverse reactions] should include: Monitoring data show that the paediatric anti-phlegm and anti-cough preparations have vomiting, nausea, diarrhea, abdominal pain, rash, itching, sweating, dizziness, headache, Allergic reaction and other adverse reaction reports
.
2.
[Contraindications] items should include: Those who are allergic to this product and its ingredients are prohibited
.
3.
[Notes] items should include: 1.
Avoid spicy, cold and greasy food
.
2.
Babies should be used under the guidance of a physician
.
3.
Patients with liver disease, kidney disease and diabetes should take it under the guidance of a physician
.
4.
Use with caution in children with heart disease
.
People with spleen deficiency and easy diarrhea should take it with caution
.
5.
This product contains ephedrine hydrochloride
.
Athletes should use it with caution; patients with glaucoma should use it under the guidance of a physician; if there are symptoms such as dizziness, headache, tachycardia, and excessive sweating after taking it, consult a physician or pharmacist
.
6.
This product is a Chinese and Western medicine compound preparation for expectorating phlegm and relieving cough.
It is suitable for mild cough due to lung heat in children
.
7.
Take it strictly in accordance with the usage and dosage, and do not overdose
.
8.
This product should not be taken for a long time.
If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital for treatment
.
9.
People with allergies should use with caution
.
10.
It is forbidden to use when the properties of this product are changed
.
11.
Children must be used under adult supervision
.
12.
Please keep this product out of the reach of children
.
13.
If you are using other medicines, please consult your physician or pharmacist before using this product
.