Individuals may or may not experience all of these symptoms, but the most common signs of an oncoming cold sore typically include:1

  • Fever
  • Red, swollen skin around the area of forming cold sore
  • Pain, tingling, and/or burning sensation around your mouth and lips

Cold sores typically last one to two, or more, weeks, but you may be able to minimize the time you have to endure your next cold sore by taking action at the first sign of an outbreak. That’s why it’s so important to know the symptoms of a cold sore in development.

If you are a frequent cold sore sufferer, consult your physician and ask if prescription Sitavig® (acyclovir), 50mg Muco-Adhesive Buccal Tablet is right for you.

In clinical trials, Sitavig was shown to reduce cold sore duration, increase the amount of time between cold sore outbreaks and, in some cases, even stop cold sores from forming.2


1 – WedMD (June 04, 2014). Cold Sores – Topic Overview [Skin Problems & Treatments Health Center web post]. Retrieved August 15, 2015, from http://www.webmd look what i

2 – Bieber T, et al. Efficacy and Safety of Acyclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial. J Drugs Dermatol. 2014;13(7):791-798. View study (link will lead you to the JDD site).


Sitavig should not be used in patients with known hypersensitivity to acyclovir, milk protein concentrate, or other components of the product.

Sitavig has not been studied in pregnant women or in immunocompromised patients and no interaction studies have been performed. Sitavig’s safety and efficacy have not been established in pediatric patients.

Sitavig is a Pregnancy Category B product; therefore it should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known if Sitavig is excreted in breast milk; however, systemic absorption is minimal.

In a controlled clinical trial Sitavig’s most common side effects (greater than or equal to 1%) were: headache (3%), dizziness (1%), lethargy (1%), gingival pain (1%), aphthous stomatitis (1%), application site pain (1%), application site irritation (1%), erythema (1%) and rash (1%). In the same trial these side effects ranged from 0%-3% for placebo.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

View Full Prescribing Information.