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On April 27, the State Food and Drug Administration issued an announcement that the compound Banlangen granules would be converted to over-the-counter drugs.
Before July 24, 2021, the holder of the relevant drug marketing authorization shall submit a supplementary application for the revision of the drug label in accordance with the "Administrative Measures on Drug Registration" and other relevant regulations, and submit it to the provincial drug supervision and administration department for the record, and timely notify the relevant contents of the revision of the label Medical institutions, pharmaceutical companies and other units.
The contents of the non-prescription drug inserts other than those specified in the template inserts shall be implemented in accordance with the original approval documents.
Attached
Over-the-counter drug instruction template
Compound Banlangen Granules Instructions
Please read the instructions carefully and follow the instructions to make use or purchase and use under the guidance of pharmacists.
Please read the instructions carefully and follow the instructions to make use or purchase and use under the guidance of pharmacists.
Generic name: Compound Banlangen Granules
Chinese Pinyin:
[Ingredients]
[Properties]
[Functions and Indications] Clear heat and detoxify, cool blood.
[Specifications] 5 grams per bag (equivalent to 15 grams of native medicine)
[Usage and Dosage] Orally, 5 grams each time, 3 times a day.
[Adverse reactions] Monitoring data shows that this product has reports of adverse reactions such as diarrhea, abdominal pain, nausea, vomiting, abdominal discomfort, itching, rash, dizziness, and allergic reactions.
[Taboo]
People who are allergic to this product and its ingredients are forbidden.
[Precautions]
1.
2.
3.
4.
5.
6.
7.
8.
People with allergies should use it with caution.
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 reach of children.
12.
If you are using other drugs, please consult your physician or pharmacist before using this product.
[Drug interactions] Drug interactions may occur if used with other drugs at the same time, please consult your physician or pharmacist for details.
[Storage]
[package]
[Validity period]
[Executive Standard]
[Approval Number]
[Revision Date of Specification]
[manufacturer]
Company Name:
Production address:
Postal code:
telephone number:
fax number:
URL:
If you have any questions, you can contact the manufacturer