U*X*L Encyclopedia of Drugs and Addictive Substances

Over-the-Counter Drugs

Over-the-Counter Drugs


What Kind of Drug Is It?

Over-the-counter (OTC) medicines are preparations that are sold to consumers without a doctor's prescription. The most common OTC medications are used to treat aches and pains, allergies, drowsiness, and cold and influenza (flu) symptoms. OTC drugs are also commonly used to remedy coughs and sore throats, constipation (the inability to have a bowel movement), and diarrhea (loose, watery, or frequent bowel movements).

Other ailments that are relieved by OTC drugs include insomnia (having difficulty falling asleep or being unable to fall asleep); motion sickness; nausea (an upset stomach, sometimes combined with vomiting); and obesity (being extremely overweight). Herbal dietary supplements and vitamins are also sold over the counter. Volumes could be written on the use and abuse of OTC medications. The following entry attempts to provide as much relevant information as possible for the scope and intended audience of this encyclopedia.

Overview

The Italian adventurer Casanova (1725–1798) is often quoted as saying: "In wise hands, poison is medicine. In foolish hands, medicine is a poison." Such is the case with over-the-counter (OTC) drugs—those medicines found on shelves in drugstores, convenience stores, and supermarkets. The sale of nonprescription drugs, vitamins, and herbal dietary supplements is a multi-billion dollar industry. Improper use of these medications, however, can be dangerous. Some individuals take OTC drugs not for medical reasons but for recreational use. In other words, they take the drugs to get high.

Official Drug Name:
Anti-allergy drugs/antihistamines/decongestants: brompheniramine maleate (BROME-fenn-IRR-uh-meen MAL-ee-ate; Dimetapp), chlorpheniramine maleate (KLOR-fenn-EAR-uh-meen MAL-ee-ate; Clor-Trimeton, Coricidin, and Sudafed), diphenhydramine hydrochloride (dye-fenn-HY-druh-meen high-droh-KLOR-ide; Benadryl), guaifenesin (gwy-FENN-ess-inn; Humibid, Organidin NR, and Robitussin), hydrocortisone (HIGH-droh-KORE-tihzone; Hydrocort and Westcort), loratadine (lor-AT-ih-deen; Claritin), and pseudoephedrine hydrochloride (SUE-doh-ih-FEH-drinn or sue-doh-EFF-ih-drinn high-droh-KLOR-ide; Sudafed; also some forms of Claritin);
antiemetics: dimenhydrinate (di-men-HI-dre-nat; Dramamine) and meclizine hydrochloride (me-KLI-zeen high-droh-KLOR-ide; Antivert and Dramamine II Less Drowsy);
antitussives: dextromethorphan hydrobromide (deks-troh-meth-ORR-fan high-droh-BROH-mide; Robitussin and Coricidin);
dietary supplements: herbs or other botanicals, minerals, and vitamins;
pain relievers: acetaminophen (uh-SEE-tuh-MINN-uh-fenn; Tylenol), aspirin, ibuprofen (EYE-byoo-pro-fenn; Advil and Motrin), dyclonine hydrochloride (DYE-kloe-neen high-droh-KLOR-ide; Sucrets), phenol (FEE-nole; with or without menthol; Cepacol, Cepastat, and Chloraseptic);
sleep aids: diphenhydramine hydrochloride (dye-fenn-HY-druh-meen high-droh-KLOR-ide; Nytol, Sominex, and Unisom SleepGels), doxylamine succinate (dok-SILL-uh-meen SEK-sehnate; Unisom SleepTabs);
stimulants: caffeine (Caffedrine, No-Doz, and Vivarin);
stomach/intestinal remedies: bisacodyl (biss-ah-COE-dill; Correctol and Dulcolax), bismuth subsalicylate (BIZ-muth sub-sah-LISS-uh-late; Kaopectate and Pepto-Bismol), calcium carbonate (Rolaids and Tums), docusate (DOE-coo-sate; Colace), kaolin and pectin (KAY-oh-lin and PEK-tin; Kapectolin and K-P), loperamide hydrochloride (loe-PER-a-mide high-droh-KLOR-ide; Imodium), magnesium hydroxide (Phillips' Milk of Magnesia), psyllium (SIH-lee-um; Fiberall and Metamucil), senna (Exlax and Senokot), simethicone (sy-METH-ih-cone; Gas-X and Mylanta)

Also Known As: Various; some examples include: downers (for diphenhydramine and doxylamine); red devils, skittles, triple-C (for dextromethorphan hydrobromide); and uppers (for caffeine)

Drug Classifications: Not scheduled or Schedule V; sold without a prescription

In From Chocolate to Morphine, Andrew Weil and Winifred Rosen noted, "Sometimes, people who are desperate for drugs … consume overdoses of these preparations in an effort to get high." Still others turn to OTC drugs in suicide attempts. Illicit drug makers often use the ingredients found in certain over-the-counter preparations to create designer drugs in homemade labs. Harmful and addictive, designer drugs are sold illegally on the streets by drug dealers looking to turn a sizable profit.

From ancient times to the twenty-first century, people have experimented with plants and even animals for use in medicines. Every human culture has used its regional plant life to cure ills—or at least to ease them. Home remedies were passed down from generation to generation, with parents teaching children what herb or plant to grow to cure various ailments. Plants with greater potency, or strength, especially those with hallucinogenic properties, generally became the tools of the trade for the shaman or medicine man of the indigenous, or native, peoples. (Hallucinogens are capable of producing visions or hallucinations, which alter the user's perception of reality.) Shamans, who closely guarded the secrets of their potions, were trained spiritual leaders who sought to cure the sick and uncover hidden truths. By the time of the great ancient civilizations of Egypt, Greece, Rome, and the Mayan empire, scholars were already writing texts on medicines and poisons. The medical profession had been established.

Patent Medicines Are Introduced

In the nineteenth century, few laws existed in the United States to regulate what ingredients went into medicines, or what sort of medicines could be sold. Traveling salespeople could peddle "patent medicines," which were over-the-counter drugs containing secret ingredients not listed on the label, and "tonics" and "elixirs" that promised they could cure just about anything. In those days, truth in advertising wasn't practiced by many who were looking to make a quick buck.

Larger companies manufactured bottled products, sold over the counter, with comforting names like "Mrs. Winslow's Soothing Syrup." No laws required that these products contained labels listing their ingredients. Plus, drug makers did not have to prove that their tonics actually worked or could achieve anything close to what advertisements claimed these medicines could do.

Patent medicines fell into two categories: 1) Those containing drugs such as alcohol, cocaine, heroin, marijuana, morphine, and opium; and 2) those containing little or no drug content at all. (Separate entries on alcohol, cocaine, heroin, marijuana, morphine, and opium are also available in this encyclopedia.) Many people used these medicines thinking they were effective and safe. Some even gave the products to their children and infants.

Addictions Run Rampant and the Government Steps In

As the twentieth century began, however, babies and children frequently faced addiction and death from so-called tonics containing narcotic drugs. Such drugs are painkillers that can easily become habit-forming. Grown men and women became dependent on their "medicines," thinking that they needed the tonics in order to function. They were unaware that they were consuming dangerous, addictive drugs.

This development, combined with fears about unsanitary conditions in meat-packing plants, led Congress to enact the Food and Drugs Act in 1906. With the passage of this act, the U.S. government took the first steps toward the regulation of patent medicines. The Food and Drugs Act did not ban any specific medicines, but it did require that companies list the medicine's ingredients on the label. Finally, Americans could look at a bottle of tonic and know exactly what it contained.

What's in a Name?


Patent medicine advertisements made all sorts of claims about what certain products could do for the consumer. Many promised they could "cure whatever ails you," while others just promised to treat specific ailments. In some cases, the medicines failed to produce any relief or led to addiction of various drugs, such as cocaine. Other home remedies did provide some relief.

Here's a look at some of the interesting names of patent medicines from that bygone era.

  • Cocaine Tooth Drops
  • Christie's Magnetic Fluid
  • Dr. J. Hostetter's Stomach Bitters
  • Dr. Morse's Indian Root Pills
  • Dr. Pierce's Golden Medical Discovery
  • Gooch's Mexican Syrup
  • The Great Dr. Kilmer's Swamp-Root Kidney Liver & Bladder Cure Specific
  • Lash's Kidney and Liver Bitters
  • Lydia E. Pinkham's Vegetable Compound
  • Mrs. Winslow's Soothing Syrup
  • M&R Licorice Wafers (for throat irritation)
  • Moxie Nerve Food
  • Stanley's Snake Oil
  • Stearns' Headache Cure
  • Warner's Safe Kidney & Liver Cure

In 1914, the Harrison Narcotics Act sought to curb the use of habit-forming drugs such as opium and cocaine. This act required prescriptions for these and other addicting narcotics. In 1937, marijuana was taken off the medical market. The following year, the U.S. Food, Drug, and Cosmetic Act (FDC) required that all new drugs, both prescription and over-the-counter, be tested for safety in animal and human studies before being released to the public.

The Role of the FDA

All medicines sold in the United States fall under the regulation of the U.S. Food and Drug Administration (FDA). The agency began in 1862 as the Bureau of Chemistry. Its name was changed to the Food, Drug, and Insecticide Administration in 1927 and shortened to the Food and Drug Administration in 1930. This agency has many responsibilities that encompass safety testing, ingredient labeling, and the listing of nutritional guidelines on products that are ingested. It also regulates the ingredients in cosmetics and oversees the design of poison labels, tamper-resistant packaging, and child-proof caps on medicines and household cleaning products.

In addition, the FDA demands that drug companies label their medicines clearly, so that consumers can easily determine the proper usage and dosage information for every OTC medicine sold in the United States. The FDA must approve all medicines, both prescription and OTC, before the drugs are released for public use. Medicines that are shown to be dangerous can be recalled by the agency and removed from the market.

Every OTC medicine has undergone scientific tests, first on animals and then in controlled human studies. The FDA continues to monitor medicines after they have been approved due to concerns about long-term use of certain substances and their link to diseases such as cancer or to health risks such as liver damage. Often, medicines will first be approved for prescription use. Some eventually become OTC drugs once they prove safe.

For example, in the early 1980s, the popular pain reliever ibuprofen (Advil and Motrin) was available only by prescription. In the 1990s, the allergy drug Claritin required a prescription. In the early twenty-first century, guaifenesin (an ingredient in many OTC cough and cold products such as Robitussin) entered the OTC market after a period of prescription-only use. All of these drugs received OTC approval by the FDA only after their safety had been established.

Substances Not Under FDA Control

Some substances sold over the counter are not reviewed by the FDA. In 1976 the Proxmire Amendments stopped the FDA from limiting the potency, or strength, of vitamins and minerals contained in food supplements and from classifying high doses of vitamins as drugs. Less than twenty years later, the 1994 Dietary Supplement Health and Education Act (DSHEA) declared that herbal supplements such as St. John's wort (Hypericum perforatum) and ginseng (JINN-sing; Panax ginseng) were foods rather than drugs. As such, herbal and


dietary supplements are not typically regulated by the FDA unless a problem is reported.

"About 60 percent of U.S. consumers believe that dietary supplements must be approved by a government agency like the Food and Drug Administration before they can be sold to the public," according to the Harris Poll's Nancy Wong, as quoted in the Nutrition Action Healthletter. But that is no longer the case. The Healthletter continued: "Before DSHEA, if the FDA questioned a supplement's safety, the manufacturer had to prove that it was safe." Bruce Silverglade of the Center for Science in the Public Interest told the Healthletter, "DSHEA shifted the burden of proof." He added, "[T]hanks to DSHEA, the FDA has to prove that supplements are dangerous. …