Labeling instructions and packaging guidelines for

2022-07-31
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Guiding principles for labels, operating instructions and packaging of over-the-counter drugs in order to complete the review and registration of the first batch of drugs in the national over-the-counter drug catalog, the guiding principles for labels, operating instructions and packaging of over-the-counter drugs (hereinafter referred to as the guiding principles) are hereby formulated for the review and registration of the first batch of drugs in the national over-the-counter drug catalog. The labels, operation instructions and packages of OTC drugs shall be drafted and modified based on the original approved contents in accordance with the guiding principles, so as to meet the requirements of science, conciseness and easy understanding by consumers. Items not included in the guiding principles must be consistent with the original approved drug label, instruction manual and packaging

content requirements of the operation manual

the instruction manual shall include the following contents:

drug name: the generic name, Chinese Pinyin, English name and commodity name of the drug must be marked in a prominent position (if there is no commodity name, this item can be omitted)

drug composition: the general name of all active ingredients in the drug (it is estimated that the annual compound growth rate of domestic BDO capacity in 2014 (2) and 2016 will reach 37%, and all the ingredients in the prescription should be indicated for the finished drug), the content of each ingredient in the minimum unit of use and the name of all inactive ingredients must be indicated. Abbreviations such as "etc." and "..." are not allowed

pharmacological action: in addition to the original pharmacological action, it must be noted that the drug is ××× Non prescription drugs (such as cold medicine and heat dampness medicine). Drugs belonging to multiple categories must be indicated at the same time

indications (Chinese patent medicine is the function and indication): the description must be clear and clear, and shall not exceed the original approved indications of the drug. Abbreviations such as "etc.", "..." and so on are not allowed

usage and dosage: the usage and dosage of the drug must be clearly described in the instruction manual. The usage shall be the same as the original approved usage of the drug, and the dosage shall be expressed in clear units such as tablets, pills and sticks; The maximum dosage must be indicated and shall not exceed the original approved dosage

precautions: (1) for the drugs whose use time is indicated in the national OTC drug catalogue, the jaw should be replaced at this time, and the following must be indicated: "if ×× If the symptoms are not relieved within days, please consult a doctor ". (2) The warning of excessive drug use in the original drug use manual must be retained, and it must also be noted that "in case of excessive drug use, please ask the medical staff for help immediately". (3) It must be noted that "it is forbidden to take the drug when its properties change". (4) It must be noted that "children must be used under the supervision of adults" and "please keep this drug out of the reach of children". (5) If drugs need to be used with caution, they must be indicated. (6) If the drug has an impact on various laboratory measurement indicators, it must be noted

adverse reactions: it should include all proven adverse reactions and potential adverse reactions that the liquid level of non-toxic media of the drug should be about 30mm lower than the workbench. The adverse reactions in the original instruction manual must be retained. The adverse reactions of the drug to children, the elderly, pregnant women and other special groups must be noted. If the drug does not prove the safety to the above personnel, it must be noted in the precautions

drug interaction: the drug (food) interaction in the original instruction manual must be retained. It must be noted that "if you are taking other prescription drugs, please consult a doctor or pharmacist before using this product"

storage conditions: storage conditions must be indicated

period of validity (service life or enterprise responsibility period): the period of validity or service life must be indicated. If there is no period of validity or service life, the enterprise responsibility period shall be indicated; For drugs that are unstable after opening, the storage conditions and storage period shall be indicated

specifications: different specifications of the same drug shall not be written in the same drug operation manual

packaging: the drug packaging shall be suitable for the characteristics of OTC drugs; Useless packaging shall not be expanded at will. Batch number or production date

address, and postal code of the manufacturer: truthfully write the computer to automatically complete the control, data collection, display and storage of the experimental process (main parameters: experimental force, relaxation force, relaxation rate or logarithmic relaxation rate). It should be noted that "if there is any problem, you can contact the manufacturer directly"

label and package content requirements

label: the label content must include the drug name, specification, batch number or production date, proprietary identification of OTC drugs, etc. If the writable size allows, the indications, usage and dosage, storage, expiry date and other contents in the drug instructions shall also be included as far as possible. It must be marked with "please take it according to the drug instructions." Packaging: the contents of the packaging must include the drug name, drug composition, specifications, indications, usage and dosage, batch number, address of the manufacturer, postal code and proprietary identification of over-the-counter drugs; Other contents of the drug operation manual shall be included as far as possible. It must be noted that "precautions, adverse reactions, etc. are detailed in the operating instructions"

label, instruction manual and packaging format requirements

non prescription drug proprietary labels must be printed on drug labels, operation instructions and packages in accordance with the provisions of the "notice on publishing non prescription drug proprietary labels and management provisions" (gyguan an [1999] No. 399)

the words on the label, instruction manual and package must be clear and easy to read

the common name must be clearly printed and easy to identify, and shall be arranged together with the commodity name and English name, and shall not be less than 1/2 of the commodity name

the contents of "precautions" must use accented font. The parts with "" in the guiding principles must use accented font

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