Over-The Counter Drug Labels.

On May 16, 2002, new federal regulations that spell out what is to appear on over-the-counter drug labels went into effect. The intent is to make the labels more consumer friendly and will apply to over 100,000 over-the-counter drugs. This could help consumers select the most appropriate over-the-counter medicines and most importantly understand each drug’s risks and benefits more easily

The FDA now will require a "Drug Facts" label to be affixed on each over-the counter drug. This label, all in large type, will spell out each drugs active ingredient, the purpose of the medication, uses and specific warnings, dosage instruction and the drug’s inactive ingredients.

An active ingredient is the chemical compound in the drug that works with your body to bring relief to the symptoms that brought you to take the over-the-counter medication. Linda Katz, Deputy Director of the Division of OTC Drug Products at the FDA, indicated that the labels themselves would tell consumers which medications they should or should not take with other things they need to be taking.

Which illnesses that they may have that would not be useful to take with a particular drug. And it would also tell the consumer when to go ask their doctor or pharmacist for additional information should they have any questions. For the elderly, who are the largest cohort group of consumers of over-the-counter medications, this may prove of tremendous importance in their pursuit of health, but only if the labels are clear in their explanations and warnings and the person takes time to read the label.

For those who want more information about how the new labeling law works, we recommend a visit to, a public education initiative by the National Council on Patient Information and Education (NCPIE) that provides information about any over-the-counter drug by brand name or active ingredient. Quoting from their site: "Be MedWise seeks to promote a better understanding that over-the-counter (OTC) drug products are serious medicines and must be taken with care." The site was launched in January 2002.

The NCPIE is a coalition of 125 consumer, government, patient advocacy and public health organizations. It is concerned with patient communication about the safe, appropriate use of medicines.

Appropriate use of medication is a problem, witness the number of deaths attributed to wrong medication. One hospital in California has recently introduced the bar code onto all its prescriptions. Physicians and pharmacists can now check whether the medication and the dosage is what was prescribed, thus eliminating mix-ups.

We hope that the consumer can look forward to more steps that provide clear information on medication intake.



By Harold Rubin, MS, ABD, CRC, Guest Lecturer
May 17, 2002

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