Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Cold, Flu, & Cough Health Center

Font Size

FDA Eyeing Unapproved Cough Suppressants

FDA to Crack Down on Unapproved Drugs Containing Hydrocodone, Including 200 Cough Suppressants
WebMD Health News
Reviewed by Louise Chang, MD

Sept. 28, 2007 -- The FDA plans to crack down on unapproved prescription drug products -- including some 200 cough suppressants -- containing hydrocodone.

Hydrocodone is a narcotic widely used to treat pain and suppress coughs. The FDA is particularly concerned about unapproved hydrocodone cough suppressants (antitussives) marketed for kids, as well as the risk of medication errors involving unapproved products.

Today, the FDA announced deadlines for companies to stop marketing unapproved hydrocodone products. FDA-approved hydrocodone drugs including the painkiller Vicodin aren't affected.

Consumers have some alternatives to unapproved hydrocodone cough suppressants.

The FDA says the approved products are: Tussicaps by Tyco Healthcare, Tussionex Pennkinetic by UCB Inc., Hydrocodone Compound by Actavis Mid Atlantic, Mycodone by Morton Grove, Homatropine Methylbromide and Hydrocodone Bitartrate by Actavis Totowa, Hycodan by Endo Pharms, and Tussigon by King Pharmaceuticals.

There also are various FDA-approved antitussive products that don't contain hydrocodone. The FDA advises consumers to consult a health care professional for detailed guidance on treatment options.

About Hydrocodone

Hydrocodone is one of the strongest medications available to treat pain or to suppress cough.

The drug has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used. Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

The FDA has received reports of medication errors associated with formulation changes in unapproved hydrocodone products and reports of confusion over the similarity of the names of unapproved products to approved drug products.

As part of the drug approval process, the FDA considers the possibility of medication errors and name confusion, so that potential safety issues associated with these factors can be minimized.

Approved Drugs Not Affected

Some hydrocodone pain-relief products are FDA-approved. But most hydrocodone formulations marketed to suppress coughs haven't been approved by the FDA.

"Companies marketing these unapproved products have not demonstrated the safety and efficacy of these drugs," the FDA's Steven Galson, MD, MPH, says in a news release.

"A case in point -- no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age," says Galson, who directs the FDA's Center for Drug Evaluation and Research.

Today on WebMD

hot toddy
15 tips to help you feel better.
man sneezing into elbow
Do echinacea and vitamin C really help a cold?
teen girl coughing
Get a good night’s rest with these remedies.
elder berry
Eat these to fight colds, flu, and more.
Natural Cold Flu Remedies Slideshow
cold weather
Allergy And Sinus Symptom Evaluator
Boy holding ear
woman receiving vaccine shot
woman with fever
Waking up from sleep
woman with sore throat