Pharmaceutical labels are an important piece of communication between the pharmaceutical manufacturer and the consumer. The information on these labels must be clear, concise, and compliant with FDA regulations.
Labels both aid your business in accurately advertising the intended benefits of the product and ensure consumer safety. If someone is allergic to an ingredient but it is not listed on the label, this can create a potentially dangerous or life-threatening event for the consumer.
Additionally, if the dosage or administration instructions are not clear, this can lead to a consumer taking too much or too little of the medication. Incorrect dosage can also lead to further complications and risks. This can both harm your reputation as a pharmaceutical manufacturer and potentially create legal liabilities for your business.
So, how can you proactively protect yourself from liability and create a safer experience for consumers? Creating high-quality labels for your products is an excellent starting point.
Essential Information for Pharmaceutical Labels
In order to create compliant and effective pharmaceutical labels, there are a few essential pieces of information that must be included:
1: Name of Manufacturer and Address
The FDA requires that the name and address of the pharmaceutical manufacturer be included on every label. Why? This allows consumers to easily identify and contact the manufacturer with any questions or concerns about the product.
This also allows for quick identification and resolution in the event of a recall. Including this information on your label not only keeps you compliant but also builds consumer trust in your product.
2: Name of Product
The name of your product must be included on the label and should be easily identifiable. This helps consumers know which product they are taking and also allows for easy identification in the event of a recall.
3: Ingredient Listing
All ingredients must be listed on the pharmaceutical label in descending order by weight. This is important for two reasons: first, it allows consumers to identify any potential allergens; and second, it allows them to understand what they are taking.
Active ingredients should be listed separately from the inactive ones as well. This allows consumers to easily identify which ingredients are responsible for the therapeutic effects of the medication.
4: Dosage Instructions
Clear and concise dosage instructions must be included on every pharmaceutical label. This is to ensure that consumers understand how to properly take the medication. Dosage instructions should include frequency, route, and duration of therapy.
If the medication is for a specific population (e.g. children, pregnant women, etc.), this should also be included on the label.
5: Warnings and Precautions
All warnings and precautions related to the product must be listed on the pharmaceutical label. This allows consumers to make informed decisions about whether or not to use the product and also helps to prevent any potential accidents or adverse events.
Some common warnings that are required on pharmaceutical labels include:
- “Do not take if you are allergic to [name of ingredient]”
- “Use with caution in pregnant women”
- “May cause drowsiness; do not operate heavy machinery while taking this product”
- “Drink a full glass of water after consuming”
6: Net Quantity Contents
The net quantity contents must be clearly stated on the pharmaceutical label. This allows consumers to know how much product they are getting and also helps to prevent any potential accidental overdoses.
7: Lot/Control Number
The lot or control number must be included on every pharmaceutical label. This allows for easy identification and tracing of products in the event of a recall. In many cases, a report may identify a specific number or range of numbers that are involved in the recall so that you can determine whether or not your pharmaceutical product is unsafe to consume.
8: Expiration Date
All pharmaceutical products have an expiration date, which must be listed on the label. This helps to ensure that consumers are taking safe and effective medications. After the expiration date, the medication may no longer be effective or safe to take.
9: Storage Instructions
All pharmaceutical products must have storage instructions included on the label. This helps consumers to know how to properly store the medication so that it remains effective and safe to use until its expiration date.
Some common storage instructions that are required on pharmaceutical labels include:
- “Store at room temperature”
- “Do not freeze”
- “Keep out of reach of children”
Create High-Quality Pharmaceutical Labels for Your Business
The quality of your pharmaceutical product labels can make an immense difference in your business’s ability to protect itself from liability, maintain a positive reputation, and eliminate potential risks for some consumers. Beyond information, the quality of the label material itself also plays a critical role.
At CapPlus, we offer a wide range of high-performance pharmaceutical labeling machines that both remove the laborious process of adhering labels by hand and are also able to create consistent, durable, high-visibility solutions for your production needs. To learn more about how our packaging equipment can help you, contact us today to speak with someone from our team.