The Common Cold: Relief But No Cure

The Common Cold: Relief But No Cure

After reviewing the ingredients that go into thousands of nonprescription drug products, an FDA advisory panel has concluded that a number of them will relieve cold symptoms but there is still no cure for one of mankind's most familiar maladies. The panel studied some 90 active ingredients that are used in cough, cold, and related products and gave its views on the safety and effectiveness of each one.

by Annabel Hecht

Had you lived in ancient Rome you might have sipped a broth made by soaking Allium cepa - an onion - in warm water to relieve the symptoms of the common cold. In Colonial America you might have relied on pennyroyal tea or an herbal concoction made from such unmedicinal sounding plants as sage, hyssop, yarrow, black cohosh, buckthorn, coltsfoot, goldenseal, cubeb berries, or bloodroot. In grandma's time, lemon and honey was a favorite recipe, or in extreme cases, a hot toddy laced with rum - the amount of same determined by the age of the drinker.

Today, if you don't have an old reliable remedy to fall back on, you might take one of literally thousands of drug preparations available without prescription. Some contain ingredients reminiscent of the folk medicine of the past; others are formulated with sophisticated chemical creations. Old or new, simple or sophisticated, many of these remedies will relieve some of the familiar cold symptoms, such as stopped up nose or hacking cough. But not a single one of these products - on which Americans spend an estimated $700 million a year - will prevent, cure, or even shorten the course of the common cold.

So says a panel of non-Government experts called on by the Food and Drug Administration to study the safety, the effectiveness, and the accuracy of claims made on the labels of some 50,000 cold, cough, allergy, bronchodilator, and antiasthmatic drug products. The Panel is one of 17 set up by FDA to examine all nonprescription (over-the-counter) drugs marketed in the United States. The project, mandated by a 1962 Amendment to the Food, Drug, and Cosmetic Act which requires that all drugs be proven effective as well as safe, will eventually lead to the establishment of definitive Federal standards on ingredients and labeling claims for all nonprescription drugs.

The Panel indicated that proper use of nonprescription drugs can be effective in relieving cough, sinus congestion, runny nose, and some of the other symptoms associated with colds, allergies, or asthma. But it made clear that although these products may relieve certain symptoms they will not cure any of these conditions.

One aspect of this class of drugs that concerned the Panel was the relative scarcity of single ingredient products on the market. This is particularly true of cough and cold remedies. That's because cold and flu symptoms span a range of troubles - from stuffy nose to headaches, sore throats and coughs. Multi-symptom OTC cold and flu remedies make it easy to treat these symptoms without taking lots of pills or separate treatments.

The common cold is a self-limiting respiratory infection which lasts from one to two weeks. It usually starts with a sore throat, sneezing, and runny nose. After a few days, the nose becomes stopped up and the eyes become watery. This is followed by lethargy, aches and pains, and sometimes a slight fever. Cough may occur in the later stages. Often these symptoms do not occur at the same time. Nevertheless, almost 90 percent of cough and cold products now available contain a combination of ingredients intended to relieve a number of different symptoms. Only 46 of the cough-cold products examined by the Panel consisted of a single active ingredient.

The Panel said it is "irrational" to take a combination product unless each of the ingredients is necessary to relieve the patient's particular symptoms. Moreover, because of variations in individual reactions to drugs, fixed combinations may not be suitable for some people. Consumers need more choice in selecting the appropriate treatment for their symptoms, the Panel said, and recommended that all products to relieve cough and cold symptoms be available in both combination and single ingredient form.

Another area of concern to the Panel was labeling of cough and cold remedies. It said labeling for these products "tends to be overly complicated, vague, unsupported by scientific evidence, and in some cases is misleading." The Panel called for an end to claims that one product is superior to, stronger than, or contains more active ingredients than another, or is specially formulated. Under its recommendations such words as "cold medicine," "cold formula," or "for the relief of colds" would be banned from drug labels. Such claims suggest the product will cure a cold when the best it can do is relieve specific symptoms, the Panel said.

One of the most distressing symptoms of the common cold is sore throat and many nonprescription drug products claim to provide relief for this condition. The Panel noted, however, that sore throat can be due to serious infection which should not be treated by self-medication. It recommended that labels on cough, cold, and related nonprescription drugs limit their claimed effectiveness to "minor throat irritation" and should advise consumers to seek medical help for serious throat problems.

Timed-release formulations also came under the scrutiny of the Panel, which found advantages and disadvantages in this type of medication. Obviously it is easier to take one pill instead of two or three, especially at night, but variations in the rate at which ingredients dissolve, differences in individual patient reactions and even technical flaws in the manufacturing process could mean that the medicine could be absorbed erratically or possibly all t one time. Therefore, the Panel recommended that a four-year period be allowed for industry, in cooperation with FDA, to develop suitable tests for the standardization of all nonprescription timed-release cough-cold products and that timed-release claims not be permitted in labeling unless such claims have been documented.

Children represent a substantial portion of the consumers of cough and cold remedies, yet the Panel found that information on how these drugs affect them is "negligible or non-existent." Lacking definitive date, the Panel sought the advice of a group of experts on pediatric drug therapy in developing the following recommendations: the dose for children 6 through 11 should be half the adult dose, and for youngsters 2 through 5 it should be one quarter of the adult dose. Asthma and cough preparations should not be taken by children 2 through 5 in any amount except on the advice of a physician. Any product with an alcoholic content of more than 10 percent is not for children under 6, the Panel noted.

As for infants up to 2 years of age, the Panel said dosage should be determined by a physician and the labels on nonprescription drug products should make this clear. Labels should never carry a recommended dose for these youngsters unless the product has been demonstrated to be safe for them, the Panel said.

In reviewing all cough, cold, allergy, bronchodilator, and antiasthmatic non-prescription drug products the Panel studied some 90 active ingredients. These ingredients were divided into six groups (plus a miscellaneous classification):

  • Antitussives, which are cough suppressants.

  • Expectorants, which help bring up mucus in the bronchial airways so it can be spit out.

  • Bronchodilators, which enlarge the bronchial passages to make it easier for people with asthma to breathe.

  • Anticholingerics, which dry up watery secretions in the nose and eyes.

  • Nasal decongestants, which open up the nasal passages.

  • Antihistamines, a class of drugs used to relieve sneezing and watery and itchy eyes, usually associated with hay fever an other allergies.

Each ingredient reviewed was placed in one of three categories:

Category I - Generally recognized as safe and effective and not mislabeled.

Category II - Not generally recognized as safe and effective or mislabeled. Such ingredients and labeling claims will be removed from products within six months after FDA issues its final regulations on cough, cold, and related nonprescription drug products.

Category III - Available data insufficient to permit final classification at this time. The Panel recommended that when FDA issues its final regulations ingredients which are placed in this category be permitted to remain on the market for a stipulated length of time if the manufacturer immediately begins tests to satisfy the questions raised by the Panel.

Recommended Resources

 Sinus Survival: The Holistic Medical Treatment for Allergies, Colds, and Sinusitis 

 Mama's Home Remedies: Discover Time-Tested Secrets of Good Health and the Pleasures of Natural Living 

 The American Institute of Homeopathy Handbook for Parents: A Guide to Healthy Treatment for Everything from Colds and Allergies to ADHD, Obesity, and Depression 

 Mucinex Expectorant, Bi-Layer Tablets, 100-Count Bottle 

 SinuCleanse Nasal Wash System, Unbreakable Neti Pot With Salt Packets 

 SinuPulse Elite Advanced Nasal Sinus Irrigation System 

 Crane Demineralization Filter Cartridge for Crane Frog, Cow, Pig, Panda, Penguin and Elephant Cool Mist Humidifiers 

 Diphenhydramine HCI 25 Mg - Kirkland Brand - Allergy Medicine and AntihistamineCompare to Active Ingredient of Benadryl® Allergy Generic - 400 Count 

 Diphenhydramine HCI 25 Mg Allergy Medicine and Antihistamine Compare to Active Ingredient of Benadryl® Allergy Generic - 400 Tablets 

 Bronkaid Dual Action Bronchial Relief, Coated Caplets, 24 coated caplets 

Lucky is the cold victim who has only an annoying tickle in his throat or a stuffed up nose. The Panel found 7 ingredients both safe and effective as cough suppressants and 14 safe and effective as nasal decongestants. It recommended that one of the cough suppressants and four of the nasal decongestants which are now available only in dosage levels that require a prescription be made available in effective dosages that could be sold without a prescription.

Not so fortunate is the person whose cough is "nonproductive" or produces only small amounts of thick phlegm. Not one ingredient was found by the Panel to be both safe and effective as an expectorant. Similarly, the Panel found no ingredient both safe and effective as an anticholinergic to relieve watery secretions of nose and eyes.

Fifteen of the ingredients it studied are not generally recognized as safe and effective for cough and cold symptoms and should be taken off the market, the Panel reported. One of these is chloroform, which FDA already has banned on the basis of evidence that high doses of it can cause cancer in test animals.

A wide array of ingredients - 52 all told - were considered by the Panel to be safe enough, but further proof of their effectiveness in relieving coughs and stuffy or runny noses is needed. Scattered throughout the list are names reminiscent of patent medicines and home remedies of the past: cod liver oil, slippery elm, cedar leaf oil, horehound, camphor, menthol, and oil from the koala bear's favorite food, eucalyptus leaves. The Panel recommended that these familiar remedies - as well as the rest of the 52 whose effectiveness it questioned - be permitted to stay on the market for from three to five years if their manufacturers undertake further tests to prove (or disprove) that grandma knew all along what was good for the sniffles.

As for the labeling of cough and cold remedies, the Panel recommended that cough suppressants be permitted to claim that they temporarily relieve coughs due to minor throat irritation, help to quiet the cough reflex, or help you to cough less. But the labels should warn that a cough may be a sign of a serious condition and that a physician should be consulted if it lasts more than one week. The Panel also recommended a warning that cough suppressants should not be used for persistent or chronic coughs such as occur with smoking, asthma, and emphysema. In such cases, coughing is essential to rid the bronchial airways of mucus and other secretions. Cough suppressant labels should not refer to lung or chest conditions, the Panel said, nor should they claim the product works by soothing the bronchial passages.

The Panel said expectorant labels should be permitted to claim that the product helps loosen phlegm or rid passageways of bothersome mucus, but it called for a warning against taking expectorants for persistent chronic cough associated with smoking, asthma, or emphysema, or if there are excessive secretions, except under the advice of a physician.

Labels on anticholinergics could promise temporary relief of watery nasal discharge, or runny nose or watering of the eyes, but such statements as "clears nasal passages" or "opens airways" would not be permitted under the Panel's recommendations. Consumers should be warned not to take anticholinergics if they have asthma, glaucoma, or difficulty in urinating, the Panel said.

Topical nasal decongestants, those applied directly in the nose, present a unique problem. These drugs help clear up stuffy noses by constricting enlarged blood vessels in the nasal passage. But if they are used for too long a time or too frequently they can have the opposite effect and actually enlarge, rather than constrict, the blood vessels. Therefore, the Panel recommended that labeling for topical nasal decongestants warn users not to exceed the recommended dosage and not to use the product for more than three days. If symptoms persist, a physician should be consulted.

Oral nasal decongestant labels should warn against use by persons suffering from high blood pressure, heart disease, diabetes, or thyroid disease unless under a physician's supervision, the Panel said. And products that are inhaled should carry the caution statement: "Not for use by mouth."

Approximately six million people in this country suffer from asthma, a disease marked by wheezing, coughing, and shortness of breath. Many of these people use nonprescription drugs called bronchodilators to help them breathe more easily, and the Panel found 12 ingredients safe and effective for this purpose. Five of them are now available only by prescription, and the Panel proposed that they be changed to over-the-counter status.

Because of the variations in the way the body breaks down the two types of drugs most often used as bronchodilators, the Panel said that single ingredient preparations are more effective and safer to use than combination products. It also cautioned that bronchodilators not be used unless a diagnosis of asthma has been made and then only under the supervision of a physician.

Because bronchodilators can have adverse effects on the circulatory and central nervous systems, they should carry labels warning against use by persons suffering from high blood pressure, heart disease, thyroid disease, diabetes, or enlargement of the prostate gland, the Panel said. Labeling also should warn the patient to seek help immediately if symptoms are not relieved in one hour - or in 20 minutes in the case of epinephrine taken by an inhaler. Bronchodilator labels should be permitted to claim that the product is for temporary relief or symptomatic control of bronchial asthma only, the Panel recommended, and there should be no suggestion that it will relieve hay fever or have any effect on the nasal passages.

The relief of hay fever should be left to the antihistamines, the Panel indicated. It found 11 ingredients from this class of drugs safe and effective for relieving the symptoms of allergic rhinitis, or hay fever. Four of these are now available by prescription only, but the Panel recommended that they be approved for over-the-counter sale. Two antihistamines now used in hay fever products require further testing to demonstrate their effectiveness, the Panel said.

Although the antihistamine that are rated safe and effective have a low potential for side effects, and toxicity they may cause drowsiness, the Panel pointed out, and it said this fact should also include a warning against use by people who have asthma, glaucoma, or enlargement of the prostate gland unless under the supervision of a physician.

Acceptable label claims for antihistamines should be that they are for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy and watery eyes as may occur in hay fever, but not for the relief of nasal symptoms, such as stopped up nose, nasal stuffiness, or clogged up nose, the panel said.

Although antihistamines are widely used in the treatment of common cold symptoms, the Panel said there is "little valid evidence" that they are effective for this purpose. Claims that antihistamines are effective for cold symptoms have not been substantiated by appropriate research, the Panel said, but it suggested ways these drugs could be tested for the common cold.

The Panel considered a number of ingredients which are often found in nonprescription cough-cold preparations, but which did not fall within the six main categories under review. These included antihistamines added to some cough-cold products as a sedative or sleep-aid. The Panel questioned the validity of adding an antihistamine to a cough or cold preparation for purposes of sedation and recommended that such combinations be taken off the market. But it said combinations that include an antihistamine "for restful sleep" should be allowed to stay on the market provided testing is undertaken by the manufacturer to establish an effective dose.

The Panel also called for additional testing to prove the effectiveness of caffeine, which is added to some cough-cold products to counteract drowsiness caused by other ingredients, and phenobarbital, which is added to offset central nervous system stimulants.

Label claims that vitamins, when used either alone or in combination with other products, are effective as cold preventives or cures should not be permitted, the Panel said. But the Panel added that manufacturers should be allowed to use vitamin C in cold products for three years if they want to do so in an effort to demonstrate its effectiveness, on the condition that no claims are made about the vitamin C.

The Panel's report, the culmination of three years of study of this vast array of ingredients, is advisory in nature. It was published by FDA in the FEDERAL REGISTER to allow for comments on it, FDA will issue final standards for acceptable ingredients and labeling claims for cough, cold, and related over-the-counter drug products. As a result, many products may have to be reformulated and labeling and advertising claims may have to be changed, a process that may take place even before the final standards are issued.

Annabel Hecht is a staff writer with FDA's Office of Public Affairs.



The Panel found that the following ingredients are generally recognized as safe and effective and are not mislabeled

Antitussives (cough suppressants)
Codeine alkaloid
Codeine phosphate
Codeine sulfate
Dextromethorphan hydrobromide
Diphenhydramine hydrochloride



Nasal Decongestants
Ephedrine hydrochloride
Ephedrine sulfate
Racehedrine hydrochloride
Naphazoline hydrochloride (topical)
Oxymetazoline hydrochloride (topical)
Phenylephrine hydrochloride (oral/topical)
Phenylpropanolamine bitartrate (oral)
Phenylpropanolamine hydrochloride (oral)
Phenylpropanolamine maleate (oral)
Propylhexedrine (inhalant)
Pseudoephedrine hydrochloride (oral)
Pseudoephedrine sulfate (oral)
Xylometazoline hydrochloride (topical)

The Panel found that the following ingredients are not generally recognized as safe and effective or are mislabeled.

Hydrocodone bitartrate
Oil of turpentine (oral)

Antimony potassium tartrate
Calcium iodide anhydrous
Hydriodic acid syrup
Iodized lime
Ipecac fluidextract
Potassium iodide
Squill extract
Oil of Turpentine (oral)

Atropa belladonna (inhalant)
Datura stramonia (inhalant)

Nasal Decongestants
Mustard oil (topical/inhalant)
Oil of Turpentine (oral)

The Panel found that there are insufficient data to classify the following ingredients. It recommended that these ingredients be permitted to remain on the market from three to five years if their manufacturers immediately begin tests to answer the questions raised by the Panel.

Beechwood creosote
Camphor (topical/inhalant)
Caramiphen edisylate
Carbetapentane citrate
Cod liver oil
Elm bark
Ethylmorphine hydrochloride
Eucalyptol/eucalyptus oil (topical/inhalant)
Horehound (horehound fluidextract)
Menthol/peppermint oil (topical/inhalant)
Noscapine (noscapine hydrochloride)
Oil of turpentine (topical/inhalant)

Nasal Decongestants
Beechwood creosote
Bornyl acetate (topical)
Camphor (topical/inhalant)
Cedar leaf oil (topical)
1-Desoxyephedrine (inhalant)
Ephedrine (oral)
Ephedrine hydrochloride (oral)
Ephedrine sulfate (oral)
Eucalyptol/eucalyptus oil (topical/inhalant)
Menthol/peppermint oil (topical/inhalant)
Oil of turpentine (topical/inhalant)
Phenylpropanolamine hydrochloride (topical)
Racephedrine hydrochloride (oral)
Thenyldiamine hydrochloride (topical)
Thymol (inhalant)

Atropine sulfate (oral)
Atropine (d, dl hyoscyamine) (oral)
Scopolamine (1-hyoscine) (oral)

Ammonium chloride
Beechwood creosote
Camphor (topical/inhalant)
Compound tincture of benzoin (inhalant)
Compound white pine syrup
Eucalptol/eucalyptus oil (topical/inhalant)
Extract white pine compound
Glyceryl guaiacolate
Ipecac syrup
Menthol/peppermint oil (topical/inhalant)
Oil of turpentine (topical/inhalant)
Pine tar
Potassium guaiacol sulfonate
Sodium citrate
Syrup of pine tar
Terpin hydrate
Terpin hydrate elixir
Tincture of benzoin (inhalant)
Tolu balsam
Tolu balsam tincture
White pine

ALLERGY REMEDIES (Antihistamines)

The Panel found that the following ingredients are generally recognized as safe and effective and are not mislabeled.

Brompheniramine maleate
Chlorpheniramine maleate
Diphenhydramine hydrochloride
Doxylamine succinate
Methapyrilene fumarate
Methapyrilene hydrochloride
Phenindamine tartrate
Pheniramine maleate
Promethazine hydrochloride
Pyrilamine maleate
Thonzylamine hydrochloride

The Panel found that there are insufficient data to classify the following ingredients. It recommended that these ingredients be permitted to remain on the market from three to five years if their manufacturers immediately begin tests to answer the questions raised by the Panel.

Phenyltoloxamine citrate
Thenyldiamine hydrochloride (oral)

ASTHMA REMEDIES (Bronchodilators)

The Panel found that the following ingredients are generally recognized as safe and effective and are not mislabeled.

Ephedrine hydrochloride
Ephedrine sulfate
Racephedrine hydrochloride
Epinephrine bitartrate
Epinephrine hydrochloride (racemic)
Methoxyphenamine hydrochloride
Theophylline anhydrous
Theophylline calcium salicylate
Theophylline sodium glycinate

The Panel found that the following ingredients are not generally recognized as safe and effective or are mislabeled.

Atropa belladonna (inhalant)
Datura stramonia (inhalant)
Pseudoephedrine hydrochloride
Pseudoephedrine sulfate

The Panel found that there are insufficient data to classify the following ingredients. It recommended that these ingredients be permitted to remain on the market from three to five years if their manufacturers immediately begin tests to answer the questions raised by the Panel.

Euphorbia pilulifera

Reprinted From September 1976 FDA CONSUMER

HHS Publication No. (FDA) 77-3029

Department of Health and Human Services
Public Health Service
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Office of Public Affairs