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English
Pharmaceutical labeling refers to the process of adding labels to pharmaceutical products to facilitate the identification and understanding of important information for end-users. Since the use of pharmaceuticals can significantly affect the health and well-being of consumers, it is essential the information presented on the label—particularly in regard to usage instructions, expiration dates, and ingredient lists—is clear and accurate.
Labeling is a critical part of packaging in pharmaceutical industry, and if modern labeling systems are deployed, efficiency savings can be made without compromising on standards or regulations.
The labeling is critical to maintaining compliance. Not only does the label act as a unique identifier to prove authenticity to health care professionals, but it also ensures that active ingredients and concentrations are clearly understood. And there can’t be any margin for error as the consequences of inaccurate ingredients are too high.
1. Appearance of the pharmaceutical product (illustration with symbols, graphics or pictures of real products)
2. Dosage frequency [quantity/time]
3. Route of administration
4. Warning (esp. on medications targeting external use)
A pharmaceutical label refers to the content printed or pasted on the drug package, which is divided into an inner label and an outer label. The inner label of a drug refers to the label of a package that has direct contact with the drug, while the outer label refers to the label of a package other than the inner label.
FDA's labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug* labeling. Human prescription drug labeling (1) contains a summary of the essential scientific information needed for the safe and effective use of the drug; and (2) includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling.
1. Brand label
2. Grade label
3. Descriptive label
4. Informative label
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