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Understanding Drug Labels

- Summary
- Understanding OTC drug labels
- Prescription drug package inserts
- Herbal supplement precautions
- Drug safety tips
- Question for your doctor

Reviewed By:
Marc J. Sicklick, M.D., FAAAAI, FACAAI

Summary

Used correctly, medications can relieve symptoms, prevent disease or even cure conditions. However, reading and understanding drug labels and inserts is crucial for their safe and effective use. This is particularly true for people with certain allergic conditions.

As defined by the U.S. Food and Drug Administration (FDA), a drug is any substance (other than food or a device) intended to diagnose, cure, mitigate, treat or prevent conditions in a living organism. Many products that, on first glance, do not appear to be drugs fit this description. Mouthwash, for instance, is considered a “drug.” There are two types of drug classifications in the United States:

  • Over–the–counter (OTC) drugs. Medicines available without a physician’s prescription (sometimes called nonprescription drugs). These medicines are approved by the FDA to be used for many symptoms and conditions.

    OTC medicine labels are standardized and follow strict FDA guidelines that offer all the basic facts about a product. They contain relatively easy–to–understand words and have a consistent style. Everything from mouthwash to cough medicine has labels with detailed information that is arranged with the same format.

  • Prescription drugs. Medications that require a prescription from a physician or other qualified health professional. Prescriptions authorize a pharmacist to provide a particular medication for a specific patient, with instructions on its use. These medications are available only at the pharmacy counter. These drugs are more tightly regulated by the FDA.

    Unlike OTC drug labels, prescription drug labels are not consistent in style, layout or type of information. However, a current Patient Package Insert (PPI) with detailed information about the drug and its proper use should always be included when a prescription drug is prescribed or dispensed. These inserts are standardized according to the FDA but can vary depending upon the type of drug prescribed and the drug’s manufacturer. 

It is important to note that herbal supplements or “natural” medicines are not government regulated or approved medications. “Natural” remedies are often similar in appearance and packaging to that of OTC drugs. They may also claim to have ingredients similar to OTC drugs with similar effects. However, because they are not considered drugs, they are not regulated by the FDA or other governing agencies. Many herbal supplements have not been scientifically researched. Consequently, the use of herbal supplements is controversial.

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Review Date: 10-01-2009
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