National Food and Drug Administration: Conversion of Aloe Pearl Capsules from Prescription Drugs to Over-the-Counter Drugs

On September 27, the State Food and Drug Administration issued an announcement stating that, in accordance with the "Regulations for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)", the Aloe Pearl Capsule was transformed from a prescription drug into an over-the-counter drug after the verification and approval of the State Drug Administration

The original text is as follows:

Announcement of the State Food and Drug Administration on the conversion of aloe pearl capsule prescription drugs to over-the-counter drugs (No.

The relevant drug marketing authorization holders are requested to file with the provincial drug supervision and administration department for the revision of the label in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations before December 22, 2021, and notify the relevant medical institution of the revised content of the label in a timely manner , Pharmaceutical business enterprises 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

attachment1.

Variety list

Annex 2.

Variety of over-the-counter drug instructions template

Aloe Pearl Capsule Instructions

Please read the instructions carefully and use according to the instructions or purchase and use under the guidance of a pharmacist

[Drug Name]

Generic name: aloe pearl capsules

Chinese Pinyin:

[Ingredients]

[Properties]

[Functions and Indications] Clearing heat and leading to stagnation, promoting qi and defecation

[Specifications] 0.

[Usage and dosage] Orally

[Adverse reactions] monitoring data show that the product can see the following adverse reactions: diarrhea, abdominal pain, heartburn, nausea, vomiting, dry mouth, rash, itching, fatigue, sleepiness, fatigue, joint pain

[Taboo] People who are allergic to this product and its ingredients are forbidden

[Precautions]

1.

2.

3.

4.

5.
There is no research data for pregnant women and lactating women
.

6.
Pregnant women should use it with caution, and consult a physician if they really need to use it
.

7.
Women during menstruation and breastfeeding, and the elderly and infirm should take it under the guidance of a physician
.

8.
Strictly follow the usage and dosage.
This product should not be taken for a long time
.

9.
If the symptoms are not relieved after taking the medicine for 3 days, you should go to the hospital for treatment
.

10.
Use with caution for people with allergies
.

11.
It is forbidden to use this product when its properties change
.

12.
Please keep this product out of reach of children
.

13.
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]

[Executive Standard]

[Approval Number]

[Revision Date of Specification]

[Drug Marketing Authorization Holder]

name:

Registered address:

Postal code:

phone number:

fax number:

URL:

[manufacturer]

Company Name:

Production address:

If you have any questions, you can contact the drug marketing authorization holder