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Making Sure Drug Labels Are In Healthy Shape

This blog is for informational purposes only.  All drug labels should follow current FDA regulations.  Label Tech Inc. is not an authority on FDA regulations.  For FDA regulations click here.

A recent poll reveals that 60 percent of people using prescription drugs have made errors in taking medications.  An estimated 100,000 people in the US die every year because of medication errors.  These deaths are preventable and better pharmaceutical labels may be one of the best methods of prevention.  The quality of the labeling is extremely important to the patient's perception of the quality of the product and may have profound implications for his or her safe use of the medication and compliance with the prescribed regimen.  

This blog will examine some of the requirements for drug labels.

The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services.  A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States.  The FDA divides that responsibility into two phases: pre-approval (pre-market) and post-approval (post-market).  New drug labels must be submitted in the pre-approval stage of FDA testing.

Drug labeling refers to all of the printed information that accompanies a drug, including the label, the wrapping and the package insert.  The FDA regulation that is required to appear on a drug label depends upon the regulatory classification of the drug.  Prescription (Rx) finished drugs have very different (and much more comprehensive) drug label requirements than active pharmaceutical ingredients (APIs).  Similarly, there are very different requirements for over the counter drug labels than for homeopathic or prescription (Rx) drug labels.

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The FDA requires that drug labeling be balanced and not misleading.  The label must be scientifically accurate and provide clear instruction to health care practitioners for prescription drugs and to consumers for over the counter drugs.  Labeling regulations require that the statement of ingredients include all ingredients, in descending order of predominance in the drug.  These ingredients must also be identified by their established name.

In evaluating prescription drug labels, the FDA looks at the overall usefulness of the information that accompanies the drug.  The name of the medicine along with any critical warnings must be given top billing.  The label must describe the uses of the medicine along with the conditions under which the medicine should not be used.  The consumer must be given directions for the contraindications, for example, "Talk to your health care professional before taking this medication if any of these apply to you."

Under FDA regulations, the label must describe foods, drugs and activities that the patient should avoid while taking the medication, along with any related precautions.  The drug manufacturer must spell out the symptoms of any adverse reactions to the drug.  The FDA requires the manufacturer to collect this information.  If the patient faces any risk of drug tolerance or dependency while taking the drug, the label must contain a warning.

The label must also contain clear instructions for the correct use of the medication, including dosage and the required procedure in the event of a missed dose.  This description should cover any special instructions, such as taking the medicine with food or water.  In addition, the label should spell out storage instructions and general instructions, such as discussing questions with a health professional, because the label is not intended to be all-inclusive.  The label should warn of the danger of giving the drug to someone other than the patient.

Drug labels also detail another serious safety issue: potentially dangerous side effects that can occur if a drug is taken concurrently with another medication.  These so-called interactions are noted in the highlights section of the label.  Less important and less frequent risks are also listed farther down on the label.

When designing a drug label, be sure to consult the FDA for current drug labeling requirements.

Topics: Drug Labels FDA Approved Labels FDA Approved label printer

Taking Custom Food Labels to the Next Level

Have you noticed how many choices there are for consumers today?  I was recently searching for a pasta sauce at my local supermarket.  To my dismay, there must’ve been a hundred sauces to choose from.   Every sauce I inspected seemed to use fresh ingredients and had attractive looking labels.  In today’s competitive food market, manufacturers are looking for any advantage to set their product apart from the rest.  Now, more than ever, manufacturers realize the importance of branding in an industry that has so many choices.  Let’s take a closer look at some of the techniques manufacturers are using to help their product stand out on the shelves.

Bove’s of Vermont is a premium pasta sauce company that uses only the finest all-natural ingredients and time-tested recipes.  The company recently celebrated their 15-year anniversary and they wanted to unveil a fresh new label at the celebration.  This custom food label had to represent their rich history, as well as the freshness that characterizes their ingredients.   Bove’s used sophisticated sketches of plump, ripe tomatoes, fresh basil and roasted garlic cloves to depict some of the ingredients found in each of Bove’s six varieties of sauce.  President Mark Bove said, “Our sauces have always featured illustrations of some of our ingredients.  Based on feedback from our customers over the years, we knew we wanted the artwork on our new labels to be more refined, but to still retain some of our original whimsy and fun.”  These new labels, all designed by Vermont artist Scott Lenhardt, capture the essence of Bove’s of Vermont.  Bove’s decided to use a unique technique when it came to manufacturing the labels.  Typically a varnish is laid down on top of the inks to protect the inks and the label.  The varnish is laid down on the label with a roller.  Then a doctor blade scrapes away excess varnish and ensures it is laid down evenly.  Bove’s chose not to use a doctor blade to remove the excess varnish.  This gave the label a grainy textured feeling.  The label now has an artisanal look and feel.  This production method helped Bove’s achieve a new look while still staying true to their roots. 

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“When we took a look at the overall packaging of our products, we also saw an opportunity to really improve the look of our company logo,” said Bove. So, the red, yellow and green oval-shaped Bove’s logo was replaced, and Bove’s products now boast a more sophisticated image of a black ladle wrapped in a scripted black “B”, positioned directly above a much bolder black font.  The new logo is further highlighted by the red sauce in the background.  This custom food label shape and construction help Bove’s of Vermont stand out on the shelves among its competitors.

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Topics: food labels Custom Food Labels Food Label food label printer FDA Approved Labels FDA Approved label printer

Is Your Custom Food Label FDA Approved?

Is your custom food label FDA approved? This is the most important question for companies engaged in food processing industry that have to comply with various safety regulations. Failure to comply with these rules invites hefty fines and penalties which can be financially devastating.

Various parameters have to be accounted for to make sure that your custom food labels are FDA approved. In order to ensure standardization of food labeling procedures and to ascertain that sufficient nutritional information was brought to the knowledge of the end user, each label must contain information in a particular format to ensure easy representation of necessary information. All packaged food products are required to carry these labels. Hence, hiring the services of experts who make custom food labels is always handy to ensure that your custom food labels adhere to FDA requirements.

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An expert custom food label maker ascertains that your label features the following.

Identification mark

As per FDA compliance, the label maker ensures that every label of the food product contain the product name, the contact details of the producer as well as the size of the product.

Ingredients of the product

Each of the custom food labels must contain information regarding the contents of the product in descending order by predominance or by weight. A custom label maker lists all ingredients used in manufacturing the product in a clear and legible manner.

Serving size

FDA requires that every pack of the product clearly specify the size of the servings as well as the number of servings per pack. The professional label maker lists out nutritional break down per servings as required.

Nutritional facts

A professional custom label maker clearly specify information regarding per serving values for calories, total fat, sodium, cholesterol, total carbohydrates, protein, vitamins etc in accordance with FDA approvals.

Daily values

As per the requirements of FDA, the custom food label maker mentions percentage of daily values specifying per serving nutritional value of your product based on a 2,000 calorie a day diet.

Health claims

By listing informational evidence of claims made by your company regarding low calories, low fat, the expert label maker ensures that your custom food labels comply with FDA regulations.

Quality standards

Complying with minimum quality standard is a prime necessity and must be listed on custom food labels. Failing to do so can result in huge penalties. An experienced custom label maker list out necessary details and avoid such a situation.

Thus, various things have to be mentioned in deep detail in order to ensure that your custom food labels are FDA approved. Food labels that comply with FDA standards sell faster and get better customer response than others. All these can’t be attained without hiring a reputable custom food label maker. Businesses that don’t hire a professional label maker often fail to achieve the desired success in the long run. So, take the help of a professional custom food label maker and enjoy an edge over your competitors.

Topics: salsa label food labels food labels Custom Food Labels Food Label food label printer FDA Approved Labels FDA Approved label printer
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