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.
If the drug label involves related content, it should be revised together.
Drugs manufactured since the date of the supplementary application for filing shall not continue to use the original drug inserts.
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.
Generic name: Compound Banlangen Granules
[Functions and Indications] Clear heat and detoxify, cool blood.
Used for wind-heat and cold, sore throat.
[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.
People who are allergic to this product and its ingredients are forbidden.
Avoid smoking, alcohol, spicy, cold, and greasy food.
It is not advisable to take nourishing Chinese medicine at the same time during the medication.
It is not suitable for people with wind-cold and cold, which manifests as severe cold, mild fever, no sweat, headache, nasal congestion, clear nose, itchy throat, cough.
Patients with fever and body temperature exceeding 38.
5°C should go to the hospital for treatment.
Patients with high blood pressure, heart disease, liver disease, diabetes, kidney disease, etc.
should take it under the guidance of a physician.
Children, the elderly and the infirm, and pregnant women should take it under the guidance of a doctor.
Symptoms are not relieved after taking the medicine for 3 days, and you should go to the hospital for treatment.
People with allergies should use it with caution.
It is forbidden to use this product when its properties change.
Children must be used under adult supervision.
Please keep this product out of reach of children.
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.
[Revision Date of Specification]
If you have any questions, you can contact the manufacturer