What is Drug Labels?

A drug label refers to all printed information that accompanies a prescription or over-the-counter (OTC) medication, approved by regulatory authorities (like the FDA in the US). It is not just the physical sticker on the bottle but a comprehensive document detailing the drug’s safe and effective use. Here’s what it includes:

Key Components of Drug Labels:

1. Drug Facts (for OTC Medications):
   • Active Ingredients: Names and amounts per dose.
   • Uses/Purpose: Conditions the drug treats.
   • Warnings: When to avoid, potential side effects, interactions.
   • Directions: Dosage instructions by age/condition.
   • Inactive Ingredients: Fillers, colors, or preservatives.
2. Prescribing Information (for Prescription Drugs):
   • Boxed Warning: Serious risks (e.g., addiction, life-threatening side effects).
   • Indications & Usage: Approved medical conditions.
   • Dosage & Administration: How to prescribe/take it.
   • Contraindications: When the drug should NOT be used.
   • Warnings/Precautions: Safety monitoring requirements.
   • Adverse Reactions: Common and severe side effects.
   • Drug Interactions: Substances that alter effectiveness or risk.
   • Storage Information: Temperature, light exposure, etc.
3. Additional Details:
   • Manufacturer Info: Name, contact, lot number.
   • Expiration Date: Safe-use period.
   • NDC Code: Unique 10-digit identifier for the drug.

Why Drug Labels Matter:

• Patient Safety: Alerts users to risks (e.g., “May cause drowsiness,” “Avoid alcohol”).
• Legal Requirement: Regulators enforce accurate labeling to prevent misuse.
• Healthcare Guidance: Helps doctors/pharmacists prescribe correctly.

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