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Over-the-counter (OTC) Products

Last updated on: November 17th, 2021

The Food and Drug Administration began an exhaustive review of nonprescription products in the early 1970s. One of the issues examined closely was safe time limits for usage. Because nonprescription products may be used without any medical advice, making patients aware of time limits can be critical in ensuring their safety.

There are many reasons why nonprescription medications may have time limits for use. This article will highlight some of those reasons and provide illustrations of each. Some medications could be placed in several groups.

Serious Medical Conditions

In some cases, sustained use of nonprescription products could mask a serious underlying condition that should be diagnosed. Examples of medications in this category include laxatives (7-day use limit) and antidiarrheals (48-hour limit). Both are described in this month’s patient information page. Diarrhea may be caused by many serious etiologies, including viral, bacterial, or parasitic infection. Use of an antidiarrheal might force retention of pathogens. Persistent constipation may indicate a fecal impaction or colorectal carcinoma, among other etiologies.

Nonprescription hem-orrhoid treatments are not to be used longer than 7 days. If the problem has not resolved after this time, the patient should see a physician to rule out more serious causes of discomfort, such as anal fissures. Hemorrhoids may also progress to the point of protrusion, which may lead to soiling with fecal material, thrombosis, and bleeding of strangulated vessels.

Nonprescription sleep aids are only indicated for occasional, transient insomnia. They have a time limit of 14 days, a period sufficient for self-treating situational insomnia, perhaps due to anxiety over an upcoming wedding, examination, date, or public speaking engagement. However, insomnia may be caused by longstanding exogenous factors, such as marital friction or job worries, or by unknown endogenous factors. In these cases, the patient is better advised to seek professional help rather than use sleep aids.

Gingival analgesics treat painful areas inside the mouth, perhaps due to denture abrasion or orthodontic appliances. However, the products are never to be used longer than 7 days from the appearance of a lesion. Patients who use chewing tobacco or snuff may have developed an intraoral carcinoma. Deadening the pain could delay a physician appointment, allowing the tumor to reach the lymph system.

Sore throat products are only indicated for occasional, minor, temporary sore throat pain. They are never to be used longer than 2 days. If the problem persists longer than 7 days, the patient should seek medical care. This labeling is the FDA’s attempt to ensure that patients do not self-treat streptococcal pharyngitis (“strep throat”). Masking the pain of strep throat with lozenges containing benzocaine, menthol, dyclonine or other approved ingredients could allow the condition to become very serious.

Products for dry eye are not to be used for longer than 72 hours without seeing a physician. Minor transient problems, such as exposure to wind during a ski trip or engaging in a long bout of computer work, can be safely treated during this time. However, dry eye may be a symptom of Sjцgren’s syndrome, a morbid condition which also affects other body systems. Diagnosing it is critical in designing therapy for the related disorders (e.g., vaginal dryness, hoarseness, dry mouth, rheumatoid arthritis).

Many dermatological products have a 7-day time limit to help ensure that the patient has not contracted a serious bacterial infection. Examples include insect sting and bite analgesics, products containing topical antimicrobials and antibiotics, first-aid antiseptics, burn products, external analgesics, hydrocortisones, vaginal antipruritics, astringents and diaper rash products. Although use of these products could soothe the problem temporarily, the patient should obtain a prescription antibacterial from a physician if symptoms persist.


No Results

If a patient fits the criteria for self-use of a nonprescription product but experiences no noticeable results after a specified time, the product should be discontinued. For example, hydroquinone-containing nonprescription products are indicated for fading age spots, sun-induced freckles, and pigmentation due to pregnancy, use of estrogens or oral contraceptives. The fading they produce is a slow and gradual process, but the patient should see results in 3 months. If there is no noticeable response by that time, the risk of an adverse reaction outweighs any possible benefit to further use. Suggest a physician visit to ensure that the patient does not have a serious lesion, such as a melanoma.

Not all patients are candidates for nonprescription minoxidil products, which are only indicated for androgenetic alopecia. If the male does not see results in 12 months with 2% products or 4 months with Rogaine 5%, or if the female using the 2% product does not see results in 8 months, the product should not be used again. A physician visit should be recommended to allow differential diag-nosis of other serious causes of hair loss or use of a prescription product (e.g., finasteride).

Alternative Action Is Preferred

Occasionally, products are given a time limit for self-use to prevent patients from using them as alternatives to healthier interventions. An example of such OTCs is nonprescription diet products containing phenylpropanolamine. They are not to be used for periods exceeding 3 months. The FDA urges that during this time users develop new eating and exercise habits, rather than using the products to allow continued unhealthy lifestyle choices.

The Problem Should Have Resolved

Another group of nonprescription products has mandatory time limits because the problem should have resolved if the product was used properly and the patient actually had the problem for which the product was indicated. For example, topical products for tinea pedis (athlete’s foot) and tinea corporis (ringworm of the body) should resolve the condition within 4 weeks.

Nonprescription treatment for tinea cruris (jock itch) should clear the infection within 2 weeks. If not, a physician appointment is indicated. Other examples of products that should be discontinued if they do not produce results are treatments for fever (3 days), canker sores (7 days), headache (10 days), earwax (4 days), and warts (12 weeks) and oral nasal decongestants (7 days).

Possible Addiction

Some products, such as nicotine gum or patches, may result in addiction if overused. Nicotine-containing smoking cessation treatments are meant to be used only for the labeled period and then discontinued. Also, nonprescription nasal sprays that treat congestion can produce a rebound phenomenon if used for a period exceeding 3 days. In this case, the patient requires the product to maintain open nasal passages.

Nicotine Products Are Not for Maintenance
Nicotine has negative health effects, but its nonprescription sale is allowed with the understanding that products containing it are to be used to withdraw from smoking. However, some patients attempt to use these products as a long-term substitute for smoking, chewing or dipping. Doing so is unsafe and could produce toxic reactions. Therefore, pharmacists must point out the FDA-mandated time limits for use of nicotine-containing smoking cessation products. Nicotine gum is to be used as directed for only 12 weeks, and the patches are to be used for either 6, 8 or 10 weeks, depending on the product and strength purchased. After these times, they should be discontinued.

Conditional Time Limits

A few nonprescription products have no time limit if the patient has seen a medical practitioner. These include products for treating corneal edema (self-use not permitted without a physician diagnosis) and hypersensitive teeth (not to be used longer than 4 weeks without a a dentist’s diagnosis).

No Time Limits

Some nonprescription products have no time limits for one or more of the following reasons:

  • the condition they treat is not easily confused with any other;
  • the condition requires lifelong therapy;
  • the medications used to treat the condition are fairly safe;
  • the medication prevents a problem.

Examples include fluorides for dental care, antihistamines for motion sickness or allergic rhinitis, simethicone for intestinal gas, sunscreens to prevent sunburn, insulins, and acne medications.

Patient Information: How Long Can You Treat Diarrhea or Constipation?

When you purchase a nonprescription product, you may notice that there is a great deal of information on the label. You may be tempted to ignore or merely glance at labels and package inserts, but each piece of information is important. Over-the-counter products are sold with the understanding that you will read and follow all instructions before taking them.

Instructions include directions for safe use, precautions against using the product if you have certain medical conditions, minimum ages for safe use, and the maximum amount of time you should use the product before seeing a physician or stopping the medication. Time limits for safe use are a very important part of nonprescription product label warnings. The following explains why there are time limits for using diarrhea and constipation medications.

Diarrhea Medications

Diarrhea is usually a minor problem that will resolve after a day or two. However, in some cases, the patient may have many watery bowel movements every day for many days in a row. With each loose stool, the patient is losing fluids, which can lead to dehydration. The patient is also losing substances that his or her body needs to function properly (potassium, sodium, calcium, magnesium, bicarbonate). If your body’s supply of these substances falls too low, you could suffer problems such as an irregular heartbeat.

In the most serious cases, death may result, especially in young patients or patients who are losing additional fluid through vomiting. For these reasons, nonprescription diarrhea medicines are not to be taken for longer than two days (48 hours). The two days start when you or the patient first has a loose stool because that is the point when fluids and electrolytes begin to be lost from the body. Some patients may think they have two days of use from the time they start using the medicine, but a patient with diarrhea that has already lasted for one to two weeks could become critically ill in another two days.

If you or someone you care for is taking over-the-counter medication for diarrhea, you should try to remember the time and date when loose stools began. After 48 hours have passed, nonprescription therapy is unsafe, and you should contact a doctor.

Constipation Medications

Constipation is less likely than diarrhea to be life-threatening, so it can be safely treated with nonprescription products for a longer period: seven days. Of course, if you use a stimulant laxative (e.g., senna, bisacodyl, castor oil, aloe and casanthranol) at night, you will usually have a bowel movement the next morning and become regular again without taking anymore medication.

Therefore, most patients do not require seven full days of treatment. However, some patients overuse laxatives to the point that they take them every day. This can cause you to become dependent on the laxative, which is dangerous to the bowel, especially when stimulant laxatives are chosen. For other medications that have time limits and explanations of why they do, consult your pharmacist.

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