Dimetapp, the popular over-the-counter children’s cold and allergy medicine, was voluntarily removed from the market in 2008 by its manufacturer due to concerns over potential misuse. Dimetapp had been available since the 1960s and was a household name, making its disappearance quite noticeable. Understanding why it was discontinued requires looking at the history of Dimetapp, the active ingredients it contained, and the larger context of drug safety concerns in the 2000s.
History of Dimetapp
Dimetapp was first introduced in the United States in 1962 by Schering-Plough Corporation. It was one of the first over-the-counter cold medicines marketed specifically for children. The name “Dimetapp” was derived from two of the active ingredients it contained: brompheniramine maleate and phenylephrine hydrochloride. Brompheniramine is an antihistamine that helps reduce symptoms like runny nose and sneezing, while phenylephrine is a decongestant that dries up mucus and opens airways. Other early ingredients in Dimetapp included acetaminophen for pain and fever relief.
Dimetapp came in several colorful flavors like grape and orange to appeal to children. It was marketed as the go-to product for relieving kids’ cold and allergy symptoms. Ads emphasized how Dimetapp allowed kids to get relief without the need for doctor visits and prescriptions. By the 1970s, Dimetapp had become the #1 recommended cold medicine by pediatricians and one of the top-selling over-the-counter medications nationwide. For decades, parents gave Dimetapp to their kids when they had colds without much thought to potential side effects or misuse.
Over the years, Dimetapp’s formula evolved. The makers tweaked the ingredients, removing compounds like acetaminophen that were added to other products. They introduced new flavors and forms like meltaways and elixirs. Dosage delivery systems changed from spoon measurements to calibrated droppers and cups. But Dimetapp’s core ingredients – the antihistamine brompheniramine and the decongestant phenylephrine – remained consistent over most of its history.
Dimetapp’s Active Ingredients
Brompheniramine maleate is an antihistamine, meaning it blocks the action of histamines in the body and helps alleviate symptoms like:
- Sneezing
- Itchy, watery eyes
- Runny nose
- Itching of the nose and throat
Phenylephrine hydrochloride is a decongestant that works by constricting blood vessels in the nasal passages. This helps reduce congestion and open airways. Its effects include:
- Relieving nasal congestion
- Opening sinus passages
- Drying up excess nasal secretions
Together, the antihistamine and decongestant in Dimetapp addressed many of the major symptoms kids experience with colds and allergies. This made it a broadly effective pediatric cold medicine.
However, brompheniramine and phenylephrine both have the potential for misuse if taken in larger doses than recommended:
- Brompheniramine can cause drowsiness
- Phenylephrine can elevate heart rate and blood pressure
These concerns became magnified by the early 2000s as reports of medication abuse and accidental overdoses increased.
Drug Safety Concerns in the 2000s
In the early and mid-2000s, worry grew over the misuse of common over-the-counter medications, including:
- Abuse of medications to get high
- Accidental overdoses by both children and adults
Regulators and public health agencies responded by taking a closer look at ingredients in popular cold, allergy, and pain relief products. They identified compounds that posed risks if taken in larger quantities than recommended, especially in children. These included:
- Dextromethorphan (DXM) – cough suppressant sometimes abused by teens seeking a “high”
- Pseudoephedrine – decongestant that could be chemically processed into methamphetamine
- Antihistamines like brompheniramine – caused drowsiness at high doses
- Stimulant decongestants like phenylephrine – elevated heart rate and blood pressure at high doses
Given these concerns, the FDA implemented new regulations around 2006 that led to the reformulation of many popular cold and allergy medications:
- Added warnings about misuse potential
- Set limits on package quantities to reduce potential for abuse
- Required child safety caps on all OTC medication bottles
- Restricted availability of products containing pseudoephedrine
Manufacturers also began altering their products’ ingredients to reduce risks. For example, many brands replaced pseudoephedrine with phenylephrine in their decongestants.
Impact on Dimetapp
As an established pediatric cold medicine, Dimetapp faced scrutiny around its ingredients brompheniramine and phenylephrine during this period of heightened drug safety concerns:
- Brompheniramine could cause drowsiness if accidentally overdosed by children
- Phenylephrine could elevate heart rate and blood pressure if abused
Although Dimetapp had been used safely for decades, the risks associated with its ingredients were enough for manufacturer Schering-Plough to decide to pull it from shelves. This voluntary withdrawal of Dimetapp occurred in 2008.
Later Reformulations and Availability
After the original Dimetapp was discontinued in 2008, the brand name was later revived by different pharmaceutical companies with new formulations:
- 2009 – Perrigo reintroduced Children’s Dimetapp, replacing brompheniramine with a different antihistamine, chlorpheniramine maleate. It still contained phenylephrine.
- 2011 – Prestige Brands launched Dimetapp Children’s Cold & Cough, now with neither brompheniramine nor phenylephrine. It contained acetaminophen for pain/fever relief and diphenhydramine as an antihistamine.
These reformulations allowed Dimetapp to come back to the market in recent years, but without the original ingredients that led to its discontinuation. Today, Dimetapp Children’s Cold & Cough is available at many major retailers. However, availability of the original Dimetapp with brompheniramine and phenylephrine has not returned.
Reasons for Discontinuation
In summary, Dimetapp was voluntarily discontinued by its manufacturer in 2008 due to two key factors:
- Safety concerns over misuse potential of ingredients – Specifically brompheniramine (drowsiness) and phenylephrine (increased heart rate/blood pressure) at high doses.
- Changing regulatory environment – Tighter rules around safety caps, purchase limits, and pediatric medication risks led the company to reevaluate products like Dimetapp.
Although Dimetapp had a long history of safe use, its core ingredients ultimately did not align with the concerns around child safety and medication misuse that emerged in the 2000s. While the brand later returned to market in different formulations, the original combination of brompheniramine and phenylephrine viewed less favorably today remains unavailable.
Impact on Consumers
For consumers, especially parents, the disappearance of original Dimetapp was noticeable. It had been a go-to pediatric cold medicine for nearly 50 years. Parents searching pharmacy shelves for the familiar Dimetapp brand likely felt its absence. The newer formulations under the Dimetapp name differ substantially in their active ingredients.
More broadly, the voluntary withdrawal of Dimetapp was part of a larger trend of medication manufacturers reformulating or discontinuing established products to align with evolving safety standards. While impactful for consumers in the short term, these changes helped safeguard children and reduce prescription drug misuse risks. Today’s tighter regulations around pediatric medications can give parents greater confidence.
Alternatives for Parents
Parents today have many options for safely relieving children’s cold symptoms, including:
- Acetaminophen for pain/fever relief
- Saline drops for nasal congestion
- Vapor rubs for coughs and congestion
- Products containing diphenhydramine as a mild antihistamine
Reading labels carefully, dosing properly, and always consulting a pediatrician for guidance can help parents find effective over-the-counter cold remedies under today’s more stringent regulations.
Conclusion
Dimetapp had been trusted for generations, but concerns over misuse of its ingredients brompheniramine and phenylephrine led manufacturer Schering-Plough to voluntarily remove it from the market in 2008. Tighter regulations around children’s medications and heightened worries over prescription drug abuse created an environment where the original Dimetapp was viewed less favorably. The brand later returned under new formulations more aligned with modern safety standards. While the original Dimetapp remains unavailable today, its discontinuation was part of broader changes to better protect child health and reduce medication risks.