Correspondence
Labels for Nonprescription Medications
N Engl J Med 1993; 329:280-281July 22, 1993
- Article
To the Editor:
We are writing about two instances in which we believe that good labeling practices have not been followed for nonprescription medications.
In the first instance, Sandoz Corporation is marketing new preparations of Triaminic Syrup and Triaminic Expectorant that are half the strength of the old formulation.1 Presumably, the new formulation makes the medication easier to give to young children. Unfortunately, the label does not indicate that the new preparation is half the strength of the old one; it states only that the product is “new and improved.” Furthermore, the label and color of both the new and the old preparations are essentially identical (except for the fine print listing the ingredients). Since the old preparation is still being sold, we are concerned that some children may accidentally receive twice the recommended dose if the old formulation is used but is thought to be the new one.
In the second instance, Schering-Plough is marketing Chlor-Trimeton “Non-Drowsy Formula,” which contains no chlorpheniramine maleate, even though the brand name Chlor-Trimeton has been used synonymously with the generic name for more than 30 years. The new preparation in fact contains 60 mg of pseudoephedrine sulfate. Yet, other than the addition of the term “non-drowsy formula” to the label, there is no clear indication that the product does not contain chlorpheniramine. Someone could mistakenly take the “non-drowsy” preparation without being aware that it contains a sympathomimetic agent that could cause adverse reactions in people with underlying conditions such as coronary artery disease.
New preparations of nonprescription medicines should be labeled unambiguously so that they can easily be distinguished from existing preparations. Changing the formulation of a medication without clearly modifying the label could be dangerous.
1 ReferencesStephen J. Levine, M.D.
442 NW 20th St., Oklahoma City, OK 73103Terri L. Barton, Pharm.D.
University of Oklahoma Health Sciences Center College of Pharmacy, Oklahoma City, OK 73190Author/Editor Response
A spokesman for Schering-Plough replies:
To the Editor: The Chlor-Trimeton brand of allergy-treatment products has been available either by prescription or over the counter for more than 30 years. Products under this brand name include Chlor-Trimeton Allergy Tablets containing chlorpheniramine maleate as the active ingredient; Chlor-Trimeton Allergy Decongestant Tablets containing pseudoephedrine sulfate in addition to chlorpheniramine; Chlor-Trimeton Sinus Maximum Strength Pain Relief Caplets containing acetaminophen, phenylpropanolamine hydrochloride, and chlorpheniramine; and Chlor-Trimeton Non-Drowsy Decongestant Tablets, with pseudoephedrine as the single active ingredient. Each of these products is clearly labeled with a description of the ingredients and the symptoms they are intended to relieve, in addition to indications and precautions to ensure proper use. Furthermore, the packages were designed to highlight various formulations and assist consumers in choosing the proper product. This has been a common practice for over-the-counter pharmaceutical agents for decades.
In the case of Chlor-Trimeton Non-Drowsy Decongestant Tablets, the front panel of the package clearly states that the active ingredient is pseudoephedrine sulfate, designates the product as a decongestant in a large typeface, and highlights the fact that the product relieves nasal congestion. This product was created to meet the needs of consumers who want the benefits of decongestants without the need for an antihistamine. In contrast, the principal panel of the carton of Chlor-Trimeton Allergy Tablets, which contain only chlorpheniramine maleate, describes the product as containing an antihistamine, lists the sole active ingredient, and indicates that the product is for relief of sneezing, itchy, watery eyes and itchy throat, and runny nose.
Different types of drug products are commonly offered under a single brand name to meet the varying health care needs of the consumer while reinforcing the quality standard that a consumer has come to associate with that brand name. The Chlor-Trimeton brand name has been used with decongestant-containing products for more than 15 years. Our experience with consumers during this period indicates that they are having no serious difficulty in distinguishing the various Chlor-Trimeton products.
John M. Clayton, Ph.D.
Schering-Plough HealthCare Products, Liberty Corner, NJ 07938Author/Editor Response
A spokesman for Sandoz replies:
To the Editor: Sandoz Consumer Pharmaceuticals reformulated Triaminic Syrup and Triaminic Expectorant in 1992 because research showed that good taste is vital to good compliance, especially among children. The only practical way to improve the taste was to decrease the concentration of the active ingredients and, consequently, to adjust the dosing regimen to ensure that efficacy was not compromised. Our research has shown that the new formulations achieve our goal; in taste tests conducted with children from 6 to 11 years of age, the majority preferred the new formulations.
In introducing the new formulations, we took great care to ensure that the new products could be differentiated from their predecessors. The new Triaminic was packaged in a carton that clearly emphasized the improved taste and new dosing instructions. The carton also made it easy for consumers to distinguish the new product from the old one in stores. Moreover, the carton enhanced the readability of the label and made it possible to add a new dosage chart to both the bottle label and the carton. Approximately half of one carton panel is devoted to a description of the dosing requirements. Finally, each new Triaminic product contains a dosing cup that advises users to “Read label directions.”
The Food and Drug Administration (FDA) has established comprehensive labeling requirements for drug products with respect to indications, directions, and warnings. The label of each Triaminic product contains accurate and complete information about the ingredients, directions, and warnings -- in full compliance with FDA requirements. Moreover, several national consumer surveys over the past few years have consistently shown that consumers who use over-the-counter medicines read the labels. Consumers are particularly cautious when treating their children with over-the-counter medicines, as well as other medicines. In a recent survey, 96 percent of parents said they read the label on their children's medicine, and only 2 percent said they did not.1 Studies by Sandoz have shown that 99 percent of Triaminic users read the label when treating their children.
1 ReferencesRichard Paul, M.D.
Sandoz Pharmaceuticals Corporation, East Hanover, NJ 07936
