The “secret” in the drug label

Hu Limei Yin Limei

A drug insert is a legal document that contains important information about a drug and a legal guide for selecting a drug. The instruction manual of each drug is the identity symbol of the drug. It records the drug’s “name”, “birthday”, “ID number”, “home address” and other related information, as well as its treatment and use information. . Let’s take a Chinese patent medicine as an example to briefly introduce the “secret” in the instruction manual of a Chinese patent medicine.

Approval date The approval date is equivalent to the “date of birth” of the drug, which is the time when the State Food and Drug Administration approved the drug registration, and the revision date is the time of previous revisions after registration, generally the drug The date on which the manufacturer revises the instruction manual in a timely manner according to the safety and effectiveness of the drug after it is on the market.

“OTC” logo The “OTC” logo is a logo to distinguish between prescription drugs and non-prescription drugs. The “OTC” logo is a non-prescription drug, that is, it does not require a prescription from a licensed physician and a licensed assistant physician. Consumers can Judge the medicines purchased and used. According to the safety of drugs, non-prescription drugs are divided into two categories: A and B. Drug inserts without the “OTC” logo are prescription drugs, which can only be purchased, prepared and used with the prescription of licensed physicians and licensed assistant physicians.

Labels for external use drugs are only for external use, not for oral use, injection, instillation or inhalation, only for liquid or semi-solid on the body surface or some specific mucosal sites. Or solid traditional Chinese medicine and natural medicine, all need to be marked with the label of external medicine. For traditional Chinese medicines and natural medicines that can be used both internally and externally, the label of external medicines may not be marked.

The ingredients include all the flavors or effective parts, active ingredients, etc. in the drug prescription, and the names of all the excipients used in the injection should also be listed; if the prescription contains excipients that may cause serious adverse reactions, they should be The name of the excipient should also be listed under this item.

Traits Traits are the “appearance” of the drug. The appearance of the drug has the meaning of identification and can reflect the internal quality and authenticity of the drug to a certain extent.

For example, the “properties” of Ganmao Qingre Granules are described as follows: This product is brownish-yellow granules with a sweet and slightly bitter taste. If the purchased Ganmao Qingre Granules has agglomeration or the color has turned brown-black, it means that its properties have changed and its internal quality has been affected. It is recommended that you do not take such medicines.

Functional Indications Functional Indications refer to which diseases this Chinese patent medicine can treat or which symptoms can be improved or relieved. For example, Ganmao Qingre Granules are suitable for symptoms such as headache, fever, aversion to cold and body pain caused by wind-cold cold, but not for symptoms such as fever caused by wind-heat cold or Shushi cold.

Specifications, usage and dosage Before taking Chinese patent medicines, it is necessary to carefully read the specifications, usage and dosage of the medicines. It tells us the minimum unit amount of Chinese patent medicines and “how to use it, how much to use, and when to use it”. For example, the “Usage and Dosage” of Chuanxiong Chatiao Granules is described as follows: after meals, take it with warm boiled water or strong tea, 1 bag at a time, 2 times a day.

Adverse reactions, contraindications, precautions Adverse reactions are the harmful reactions that may appear unrelated to the purpose of treatment under the premise of correct use of drugs.

Contraindications, also known as “inappropriate”, are to ensure efficacy, safe medication, and avoid toxic side effects.

Precautions are what we should pay attention to when taking the medicine.