A Pharmacist's Guide to OTC Therapy

SEPTEMBER 01, 2007
Yvette C. Terrie, BSPharm, RPh

Cold Sore Products

Herpes simplex labialis (HSL), also commonly referred to as cold sores or fever blisters, typically is caused by the herpes simplex virus 1 (HSV-1). HSV-2 generally is responsible for causing genital herpes. Either form of the virus, however, can cause cold sores or genital herpes if the skin comes into contact with it.

Individuals may experience itching, burning, and a tingling sensation a few days before an outbreak of HSL. An outbreak can be characterized by the formation of painful, fluid-filled blisters on the lips and the edge of the mouth.1-3

Once a person becomes infected with the virus, the person is infected for life, although he or she will experience periods of dormancy and reactivation phases.1 The majority of cold sore outbreaks are self-treatable and heal within 10 to 14 days without scarring or complications.1

Numerous factors may increase incidences of outbreaks1-4:

  • Stress/fatigue
  • Ultraviolet radiation due to extreme exposure to the sun
  • Exposure to cold weather
  • Fever and/or infections due to colds or influenza
  • Trauma due to recent dental work
  • Menstruation, pregnancy, or other hormonal changes
  • Factors that may compromise the immune system (chemotherapy, radiation therapy, or immunosuppressant agents)
  • Food allergies


An outbreak of HSL can negatively impact an individual?s quality of life. The primary goals in treating HSL include relief from pain and discomfort, prevention of transmission to others, and prevention of further complications or infections.

Currently, docosanol 10% (Abreva; manufactured by GlaxoSmithKline) is the only OTC product approved by the FDA to shorten healing time as well as both the severity and the duration of the symptoms associated with HSL. This product inhibits direct fusion between the herpes virus and the human cell plasma membrane, thus averting viral replication.1,2 It is intended for external use only by individuals 12 years and older and should be applied topically 5 times daily until the sore is gone.

In addition, a number of topical OTC products?analgesics, antipruritics, anesthetics, and skin protectants?are available to provide symptomatic relief, but not for reducing the duration of symptoms1 (Table). The use of topical triple antibiotic ointments or systemic antibiotics may be necessary if the patient has any signs of a secondary infection.1

OTC Products Available for the Management of Herpes Simplex Labialis

Nonpharmacologic Measures

Individuals may benefit by incorporating the following measures1,4:
  • Use a cool, wet compress or ice on the affected area at least 2 to 3 times a day for 15 to 20 minutes to reduce swelling or erythema
  • Keep lesions clean by routinely cleansing the affected area with a mild soap solution
  • Use skin protectants to keep lesions moist, because drying and cracking may make the lesions more susceptible to secondary bacterial infection
  • Carefully wash the hands regularly with warm water and soap
  • Use sunscreen on the lips and face before exposure to the sun
  • Avoid direct contact with others when blisters are present, and avoid sharing personal items (towels, razors, silverware, etc)
  • When possible, avoid known factors that may trigger outbreaks
  • During outbreaks, avoid foods that may aggravate cold sores, such as acidic foods
  • If not contraindicated, consider the use of an OTC analgesic to alleviate pain

The Role of the Pharmacist

It is important for pharmacists to remind patients of the contagious nature of HSL lesions and of ways to prevent or reduce transmission to others. Moreover, pharmacists can identify patients who may require medical treatment. The following are examples of conditions that require referral1:
  • Cold sore lesions that are present for more than 14 days and those that display any signs of infection, such as fever, rash, or enlarged glands
  • Increased incidence of cold sore outbreaks
  • History of a compromised immune system

Headache Products

Seven of every 10 individuals experience at least 1 headache annually, and 45 million individuals in the United States suffer from chronic headaches that cost billions of dollars in lost productivity. 1

Types of Headaches

Headaches are categorized as primary or secondary. Approximately 90% are of the primary type.2 They include tension headaches, migraines, cluster headaches, and medication-overuse headaches.1-5

Tension headaches are the most prevalent, affecting 75% to 90% of adults in the United States. They are more common in women than in men.2,6 Causes include stress, anxiety, fatigue, eyestrain, and muscular tension. 2,6

Migraines are the second most common type of primary headache. They affect an estimated 20% to 25% of the population, including children.2 Women experience a greater incidence than men. The majority of women suffer migraine attacks during the premenstrual cycle or at specific times before, during, and after menses.2 Incidence is equal among boys and girls before puberty and typically disappears in boys after puberty.2

There are 2 types of migraines: with aura and without aura. Migraines may be triggered by stress; anxiety; changes in weather, altitude, and/or air pressure; hormonal changes such as during the menstrual cycle or pregnancy; environmental factors such as noise, bright lights, or certain odors; food sensitivities; alcohol consumption; use of certain pharmacologic agents (eg, nitrates, oral contraceptives, nifedipine, estrogen replacement therapy); and changes in sleep or eating patterns.2,3

Cluster headaches are the least common of the primary headaches, affecting 0.1% of the population. About 85% to 90% of individuals experiencing them are men.4,7 These headaches can occur daily in clusters of weeks or months. Individuals suspected of having cluster headaches should be encouraged to seek medical care from their primary health care provider.4,7

Secondary headaches occur as the result of another underlying medical condition (eg, sinusitis, severe hypertension, head trauma, hematomas, temporomandibular joint dysfunction, metabolic disorders, cerebral hemorrhage, and meningitis).7-9 Patients experiencing secondary headaches, those with chronic headaches, and those with severe headaches should always be referred for further medical evaluation and treatment.

OTC Therapies

A variety of OTC products are available (Table 1). These products include the following:
  • Acetaminophen
  • Acetylated salicylate
  • Nonacetylated salicylates (choline salicylate, magnesium salicylate, and sodium salicylates)
  • Nonsteroidal anti-inflammatory agents, such as ibuprofen and naproxen
Dosage forms include tablets, capsules, gel capsules, liquigels, enteric-coated tablets, extended- or sustained-release forms, liquids, suspensions, effervescent tablets, suppositories, rapid-release-gel capsules, and chewable tablets. Formulations are available as single-entity or combination products. Various formulations contain an analgesic in combination with a decongestant for individuals who suffer from sinus headaches.

Examples of OTC Analgesics for Headaches

The Role of the Pharmacist

Pharmacists can assist patients in the proper selection of products (Tables 1 and 2), first ascertaining the appropriateness of self-treatment and directing patients to seek medical intervention when warranted. Pharmacists should screen patients for possible allergies and drug interactions, as well as possible contraindications such as renal and hepatic insufficiencies, a history of gastric ulcers, or coadministration of anticoagulants.

Key Counseling Points Regarding OTC Analgesics

Pharmacists always should counsel patients on the proper use, recommended duration, and adverse effects associated with the use of these products. They should remind patients about the potential for rebound headaches that may occur with medication overuse.

Pharmacists also should advise patients to become familiar with factors that may possibly trigger their headaches and to avoid these triggers when feasible. Patients can incorporate various nonpharmacologic measures that may alleviate or reduce the incidence of headaches, such as relaxation techniques and getting an adequate amount of sleep. In addition, patients should be encouraged to contact their primary health care provider if their headaches increase in intensity and frequency.

Key Characteristics of Primary Headaches

Examples of Individuals Who Should Seek Medical Intervention


Cold Sore Products

1. Klasser G, Greene C. Oral pain and discomfort. In: Berardi RR, Kroon LA, McDermott JH, et al. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006:677-708.

2. Abreva Web site. Available at: www.abreva.com.

3. Cold Sore. Mayo Clinic Web site. Available at: www.mayoclinic.com/health/cold-sore/DS00358/DSECTION=3.

4. Cold Sores?Topic Overview. WebMD Web site. Available at: www.webmd.com/skin-problems-and-treatments/tc/Cold-Sores-Topic-Overview.

Headache Products

1. Health Care Topics: Headache, Doctors of Internal Medicine Web site. Available at: www.doctorsforadults.com/topics/dfa_head.htm. Accessed July 3, 2007.

2. Remington T. Headache. In: Berardi RR, Kroon LA, McDermott JH, et al. Handbook of Nonprescription Drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006:69-89.

3. Causes of Headaches. Excedrin Web site. Available at: www.excedrin.com/headache-causes.shtml. Accessed July 7, 2007.

4. Headache Types. Excedrin Web site. Available at: www.excedrin.com/headache-types.shtml. Accessed July 7, 2007.

5. Tension-type headaches. Bayer HealthCare Web site. Available at: www.aspirin.com/aoi/hfh/tension_type_en.html. Accessed July 7, 2007.

6. Headache. Neurology Channel Web site. Available at: www.neurologychannel.com/headache. Accessed July 5, 2007.

7. Headache. MedicineNet Web site. Available at: www.medicinenet.com/script/main/art.asp?articlekey=20628&pf=3&page=1.

8. Secondary Headaches. American Headache Society Web site. Available at: www.achenet.org/education/patients/SecondaryHeadaches.asp.

9. Headache. Merck Manual Web site. Available at: www.merck.com/mmpe/sec16/ch216/ch216a.html#CACCDJAH.

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