23280. Misbranding of Rawleigh's Tonic Compound, Rawleigh's Thyme Cough Compound, Rawleigh's Liniment, and Rawleigh's Pain Relief. U. S. v. 810 Bottles of Rawleigh's Tonic Compound, et al. Decrees of condemnation and forfeiture. Products released under bond to be relabeled. (F. & D. nos. 32654 to 32657, incl. Sample nos. 41326-A to 41329-A, incl., 56526-A, 56527-A, 56528-A.) This case involved drug preparations, the labeling of which contained un- warranted curative and therapeutic claims. On May 3, 1934, the United States attorney for the District of Minnesota, acting upon a report by the Secretary of Agriculture, filed in the district court a libel praying seizure and condemnation of certain " Rawleigh's " drug prepa- rations at Minneapolis, Minn. On or about May 7, 1934, the libel was amended, and as amended covered 810 bottles of Rawleigh's Tonic Compound, 477 bottles of Rawleigh's Thyme Cough Compound, 3,330 bottles of Rawleigh's Liniment, and 324 bottles of Rawleigh's Pain Relief. It was alleged in the libel as amended that the articles had been shipped in interstate commerce, between the dates of January 19 and April 21, 1934, by the W. T. Rawleigh Co., from Freeport, Ill., and that they were misbranded in violation of the Food and Drugs Act as amended. Analyses of the articles showed that the Tonic Compound consisted essen- tially of small proportions of sodium, potassium, calcium, iron, manganese, quinine and strychnine salts, including hypophosphites and citrates, alcohol, sugar, and water; that the Thyme Cough Compound consisted essentially of extract of thyme, alcohol, sugar, and water; that the Liniment consisted essen- tially of red pepper extract, camphor, pine oil, an ammonium compound, alcohol, and water; and that the Pain Relief consisted essentially of red pepper extract, camphor, soda, an ammonium compound, alcohol, and water. The articles were alleged to be misbranded in that the following statements in the labeling were statements regarding their curative or therapeutic effects, and were false and fraudulent: (Eawleigh's Tonic Compound, bottle label) "* * * invigorating * * *"; (circular) "Useful for * * * toning up the digestive processes in conditions of impaired nutrition for which an invigorating tonic is needed. * * * supplying nutrition and especially by aiding in correcting conditions of anemia, nervous exhaustion, general debility, and assisting in the development of rich blood and strong muscle tissue. * * * stimulating the body functions, as an aid in overcoming anemic, run down and * * * conditions of the human body. * * * to assist in restoring normal tone and to invigorate the system in many conditions in anemia, chlorosis, nervous exhaustion * * * malnu- trition and lack of normal weight. * * * aids in building up and invig- orating, or restoring normal physical processes. * * * In Anemia the blood is deficient in quantity or quality due to a lowering of hemoglobin or red color- ing matter of the blood, or a deficiency of red blood cells. Eawleigh's Tonic Compound assists natural recovery in restoring the normal processes of nutri- tion that enrich the blood. Chlorosis, a form of anemia, mostly affecting girls at the age of puberty, is commonly called Green Sickness due to the greenish pallor of the skin. The number of red cells and hemoglobin in the blood is decreased. It is marked by perverted appetite, digestive impairment, debility, dysmenorrhea, amenorrhea and nervous disturbances. Eawleigh's Tonic Com- pound with proper foods and hygienic living assists to stimulate various bodily activities that bring about a more normal condition.. Nervous Exhaustion is a depression of vital functions usually caused by prolonged and excessive expenditure of energy, insomnia, and loss of appetite. The nerves and body are tired and need rest. * * * a general toning up of the system is advisable. General Debility is a run down, weakened condition, not unlike nervous exhaustion, caused usually by sickness, overwork, improper diet and physical strain. Preceding and following childbirth, women must counteract any tendency toward this condition. Eawleigh's Tonic Compound is helpful to prevent or overcome general debility and to stimulate normal nutrition processes. It invigorates the system. When Children Grow too Fast they may outrun their physical strength and need something to stimulate nutrition and general tone of the body. Eawleigh's Tonic Compound is useful to help restore appetite, stimulate digestion and improve nutrition—important factors to help children develop into strong, robust men and women. In Convalescence the whole body is below par because of the ravages of disease, and needs to be nourished and built up. To stimulate the * * * activities of the system * * * When Weight is Under Normal Eawleigh's Tonic Compound is useful to stimulate appetite and digestive processes, toning up the body activities. Better nutrition results with corresponding increase in weight. Two Common, Unnecessary Ailments Nervous Exhaustion Nervous exhaustion, found among rich or poor, city man or farmers, brain workers or laborers, children or adults, is the result of modern restlessness and intensity of life. It was seldom found among, our forefathers, who went to bed at sundown and got up at sunrise and ate natural kinds of food with healthy appetite. Modern conveniences— telephone, electricity, trains, automobiles—keep the sense organs always dis- turbed and the body in a constant state of nerve tension. What Nervous Exhaustion Is—Nervous exhaustion is a nerve waste or depression due to the exhaustion of nerve energy. It is a group of symptoms rather than an indi- vidual disease. The Symptoms and Cause—Symptoms of nervous exhaustion can be roughly grouped into five classes—chronic fatigue, mental depression, insomnia, depressed general nutrition and digestive disorders and headaches or local pains. These symptoms are only too well known by a large number of people. Nervous exhaustion is usually preventable and caused by bad habits of living, such as lack of sleep and rest, insufficient or improper food, unsuitable work or working conditions, faulty posture, which cramps the organs of the body and causes them to function improperly, lack of exercise and too con- centrating work, autointoxication and general intemperate living. Honest work never hurts any one, though most of us like to believe we break down from working too strenuously. The wrong way of working and worrying—not overwork—causes the breakdown. Energy is wasted instead of using it in actual work. Autointoxication from constipation is an important cause, hence nervous exhaustion is one of the many results of constipation. To Prevent and Overcome This Weakness * * * Exhausted nerve cells or those using up their energy, need a tonic to start them on the right track to recovery, in addition to hygienic living and proper diet. Rawleigh's Tonic Compound is excellent because it stimulates the process of nutrition, adding certain important minerals to the blood. In this way nerve cells are kept more vigorous, replenish their lost energy, and function properly because they are well nourished. Mal- nutrition Malnutrition—A condition in which the body is not receiving proper nourishment—means that the processes of digestion, absorption, utilization and elimination are imperfect. It may be considered as partial starvation of the entire body or some parts of the body. The various tissues and organs do not receive the materials needed for growth, maintenance and repair; and so are undeveloped and below normal size. They do not receive enough food to permit normal activity, and one organ functioning improperly affects other organs; so that malnutrition of one part seriously affects the entire body. Mal- nutrition may be due to different causes—the type of food eaten and the as- similation of food. * * * Minerals are the most likely to be missing from an average diet, and they are particularly important in building and regulating the body. Malnutrition from Faulty Assimilation of Food—A sufficient quantity and proper kind of food may be eaten, but if the processes of digestion, absorp- tion, utilization and elimination are not functioning normally, the food will not be utilized properly and malnutrition results. To Prevent and Overcome Mal- nutrition—Malnutrition—found only too often in growing children, in convales- cents, in those who are underweight and in mothers before and after child- birth—has various symptoms, depending upon the organ most affected. Unde- veloped bones, as in rickets; emaciation as in long, wasting illnesses; thinness, as in children who grow too fast; lack of color and poor teeth, so often found in mothers before childbirth; poor nervous system, general tiredness or slug- gishness—these are all common symptoms of malnutrition. * * * Rawleigh's Tonic Compound * * * It stimulates * * * processes of nutrition, particularly aiding digestion. It contains several minerals necessary for good nutrition * * * minerals necessary to build muscles, bone, blood, and nerves, and to regulate the various processes of the blood. * * * the min- erals present in Rawleigh's Tonic Compound stimulate utilization of those as- similated from food, besides addition to the total quantity taken into the body, as needed. [Statements of a similar nature in foreign languages] "; (all- eges Thyme Cough Compound, bottle label) "* * * and Whooping Cough " ; (circular) "Useful In certain forms of Coughs * * * Bronchitis, Bronchial Asthma, Whooping Cough * * * Thyme Cough Compound Its Usefulness and Value in the Treatment of Coughs and Certain Related Affections * * * efficient agent for the treatment of coughs of certain kinds and related affec- tions. * * * It soothes irritated surfaces and passages of the respiratory system. * * * It also reduces frequency of cough and spasmodic attacks with consequent relief of chest pains due to straining of the muscles in cough- ing. * * * reduces the irritation of the bronchial mucosa and thus controls the irritable unproductive cough. * * * the dry, harrassing cough becomes loose, less frequent and less troublesome. The patient's sleep is no longer dis- turbed by coughing, with consequent improvement of the general health. Its Very Important that colds receive prompt attention to avoid such serious developments as acute bronchitis, spasmodic croup, or diseases of the respira- tory tract. Coughs * * * Their Cause and What Diet and Medicine Should be Used to Relieve the Infection, Congestion, Etc. * * * The term ' colds' means an acute infection of the lining membranes of the nose, tonsils, throat and nasal bronchial tubes. It may be even more extensive and develop into a general infection of the entire body. All of the breathing organs excepting the small terminal portion in the lungs may be involved and as a matter of fact the,disease or affection may, and often does, spread to these organs thus pro- ducing colds of the chest. The common cold is the most prevalent of all present- day diseases, and although statistics do not record the sum total of the ravages committed, it is evident that instead of being classed as a trivial affection, the common cold may be classed as a serious disease. The belief exists that colds are due to several causes and occur when our resistance is lowest, by intestinal disturbances, from exposure, or following chilliness and fatigue. Practically all physicians say that common colds are contagious and spread by coughing and sneezing. Almost everyone recognizes the symptoms: a chilly sensation, slight headache, pains in the back and limbs, accompanied by frequent sneezing. The mucous membrane of the nose is dry and inflamed, the nasal passage clogged making it difficult to breathe except through the mouth. A most irritating cough usually adds to the distress. The common cold may later extend into the chest where it creates a feeling of rawness and tightness. The cough usually in- creases in frequency, sometimes coming in spasms, which wrack and disturb the patient. Expectoration, is usually scanty but as soon as it becomes loose and easily ejected, marked relief is experienced. [Statements of a similar nature in foreign languages]"; (Rawleigh's Liniment, bottle label) "Useful Internally to stimulate stomach and intestines; to relieve pain of spasmodic * * * Colic * * * Coughs and Bronchial Irritations. * * * to all external pains * * * non-infectious garget, * * * treatment of spas- modic * * * colic in horses"; (circular) " For External Use * * * arousing a general invigorated activity of the tissues and skin * * * assists nature and the blood cells in rebuilding injured tissue * * * For Animals * * * It is useful for Diarrhea, Scours, Colic * * * Non-infectious Garget in Cows and Diarrhea in Poultry. For Internal Use * * * will assist nature in arousing the parts involved to renewed ac- tivity to help overcome irritations and distresses attending acute indiges- tion * * * opening the pores of the skin and permitting the elimination of certain kinds of waste from the system—all of which, is helpful in mit- igating chills * * * useful in mitigating Acute Diarrhea and Cholera Morbus. * * * Lame Back * * * Stiffness etc. * * * Direction Chart For Using Rawleigh's Liniment * * * Ague And Chills To stimu- late circulation * * * when the symptoms appear, or just before a chill comes on, take % to 1 teaspoonful of Rawleigh's Liniment in half a cup of hot water. * * * If this does not mitigate the chill, repeat the dose in from 10 to 20 minutes. In severe chills Backache * * * Swellings To increase circulation and reduce local congestion, rub Rawleigh's Lini- ment freely into the affected parts. If severe * * * Cholera Morbus Take Vi to 1 teaspoonful Liniment in warm, sweetened water or milk. Repeat the dose every 15 minutes until relieved. * * * Cramps & Colic Due to acute indigestion * * * Take % to 1 teaspoonful Liniment in % glass of warm sweetened water or milk. Repeat the dose every 15 minutes until relieved. In severe cases * * * protect the injury from infection * * * Diarrhea Take % to % teaspoonful in warm water three times a day until relieved. Take light diet and avoid foods known to cause trouble. * * * Acute Indigestion Due to overeating or improper foods. To stimulate activ- ity of digestion and mitigate the distress, take *4 to y2 teaspoonful of Liniment in warm water. * * * Pains * * * Simple Sore Throat * * * For Horses * * * Bathe with Rawleigh's Liniment to protect from infection * * * Diarrhea * * * until relieved. For Cattle * * * for Colic in horses * * * Garget Non-infectious * * * Scouring * * * For Poultry Diarrhea * * * if Diarrhea is severe. For Pigs or Lambs Diar- rea Or Scours [statements of a similar nature in foreign languages]"; (ass- igns Pain Relief, bottle label) " Pain Relief * * * Useful internally for reducing pains in stomach, bowels and intestines when caused by acute indi- gestion * * * simple diarrhoea. * * * For sick stomach"; (circular) "Pain Relief * * * A Safe * * * Pain Medicine * * * Useful in Reducing Stomach and Intestinal Pains of Colic, Acute Indigestion and Diarrhea * * * Colic * * * Scours and Diarrhea cause many losses in stock and poultry. Rawleigh's Pain Relief is useful in helping to overcome these condi- tions in stock as well as in human use. Spasmodic Colic, which is pain and cramping in the large intestine is a serious condition frequently resulting in inflammation of the bowels and becoming fatal. * * * give a horse one- fourth bottle of Pain Relief in a pint of water, repeating in a half hour if necessary. * * * Rawleigh's Pain Relief aids in stimulating the retarded digestion * * * In half an hour repeat the dose of pain relief if neces- sary. Scours or Diarrhea in calves, colts, pigs, or lambs should not be neglected. Give a colt or calf 2 tablespoonfuls, a lamb or pig 1 teaspoonful of Rawleigh's Pain Relief in a little milk, repeating the dose every two hours and keeping animal warm and dry. White Diarrhea, Cholera and Bowel Trouble in Chickens are caused by germs and are infectious and contagious. Sick fowls should be isolated * * * Rawleigh's Pain Relief, 1 tablespoonful to a pint of sweet milk or water will increase resistance and help in preventing spreading of the diseases. * * * Pain Relief * * * It is a valuable aid in relieving most ordinary cases of pain in the stomach and bowels caused by colic, acute indigestion, indigestible or tainted food, diarrhea, summer complaint * * * It is also an adjuvant in overcoming * * * simple sore throat, and La Grippe and chills accompanying colds or after exposure. Best results in stomach and bowel pains, * * * are secured by the use of a good Laxa- tive accompanying or following the use of the Pain Relief * * * How to Avoid These Pains Colic, intestinal pains and cramps * * * and diarrhea, nausea, and sickness of stomach are most usually caused by indigestion or constipation, or both, and overtaxing the digestive system with an excess of foods or improper foods, or indigestible or irritating substances * * * Some Common Internal Pains Their Causes and How Rawleigh's Pain Re- lief Helps to Overcome Them *• * * The common internal pains re- lieved by an internal medicine such as Rawleigh's Pain Relief are usually in the stomach or intestines and caused most frequently by indigestion, constipation, eating of improper or indigestible food or excess in eating or drinking, overloading the stomach with rich or irritating foods and over- taxing the digestive orKans. * * * Colic is most frequently caused from acute indigestion or the presence of irritating matter in the alimentary track. It may be due to overeating, cold drinks, eating of improper or indigestible food, and failure of the digestive organs to act vigorously and promptly. all- eges Pain Relief, 1 teaspoonful diluted in a half glass of warm sweetened water or milk will assist in reducing the colic by stimulating digestion and checking fermentation that is often present. In severe pain and cramping, in addition to taking Pain Relief internally, bathe the stomach and abdomen with Rawleigh's Liniment and cover with a hot flannel. Indigestion results from improper diet, excessive, or irregular eating, eating too fast, bad teeth, raw or cold food causing chilling of the stomach, constipation, lack of exercise, worry, and weak or inactive organs of digestion. Rawleigh's Pain Relief is intended to reduce and check the painful symptoms. When digestion stops fermentation or decomposition of the mass of food sets in and gas develops. Besides check- ing the pain it is best to remove the cause of indigestion by use of a quick acting laxative like Rawleigh's Effervescent Salts or to aid digestion with Rawleigh's Dyspepsia Tablets after eating and feeling distress. Those who are troubled with indigestion, dyspepsia or constipation should study Rawleigh's Good Health Bulletins Nos. 205 and 208, Subjects Constipation and Dyspepsia, which contain much valuable dietetical information and helpful suggestions for overcoming these common disorders. Diarrhea, Summer Complaint, Flux and Cholera Morbus are caused from some irritating substance in the alimentary canal or an intestinal infection and frequently follow indigestion or the over- eating of green fruit or vegetables, or eating of tainted food, and are common during the summer and fall, when there is an abundance of fresh food of laxative nature and when foods spoil quickly. In Diarrhea the natural course is to remove the irritating substance from the intestines and to check the irritation or infection. The use of a good laxative is advisable to assist elimi- nation and to purge the bowels of poisonous irritating matter. A warming, stimulating astringent and healing medicine will soon restore the organs to normal action, especially if one refrains from eating or eats lightly of easily digested non-toxic foods for a few meals. To reduce the pain and cramping, the griping and straining in diarrhea, Rawleigh's Pain Relief is of grateful assistance. It helps to reduce fermentation of undigested food and is warming and stimulating to the stomach and intestinal walls, helping to overcome the irritation and pain in the delicate membranes. For the pain and cramps take 1 teaspoonful of Rawleigh's Pain Relief in half a glassful of warm sweetened water or milk, repeating in a half hour if necessary. If cramps are severe, Rawleigh's Liniment may be rubbed on the abdomen and covered with warm flannel. Sickness Of Stomach, Nausea, Vomiting And Biliousness are most fre- quently caused by constipation, indigestion, or overloading the stomach or too rich or irritating food. Vomiting is a common symptom in children and may indicate the start of a contagious disease like measles, scarlet fever or chicken pox, but more often due to bowel trouble, such as constipation, or eating of too much meats, sweet or rich food that overtaxes the delicate stomach. Bilious- ness and sick headaches frequently are symptoms of constipation and delayed or slow bowel movement. The bowels should move two or three times each day. When that is the case, the troubles referred to in this circular would be unusual. To help reduce the pain and check the spasmodic straining of vomiting and to stimulate action of the stomach, Rawleigh's Pain Relief is useful in many cases. Dilute 1 teaspoonful in 10 to 15 teaspoonfuls of warm water and take a swallow every five minutes until the stomach settles and vomiting is relieved. When vomiting stops * * * While a good Pain Medicine easily taken internally and safe and reliable for family use, like Rawleigh's Pain Relief, is inval- uable for reducing the frequent painful symptoms of stomach and bowel trou- bles, most of these painful symptoms may be avoided by careful selection of food, avoiding excess of rich foods that are hard to digest, unripe fruits, or irritating, or practically indigestible foods, and by keeping the bowels regulated so that at least two normal natural movements occur every day. Colds And Lagrippe occur in various forms and one suffers from aching joints and muscles, fever and headache. Colds shouldnot be neglected. The best treatment per- haps is to go to bed and keep warmly covered after taking a hot bath or foot- bath. Rawleigh's Cold Tablets taken promptly will help to eliminate the cold from the system. Keep the bowels free with a good laxative. Rawleigh's Pain Relief, as an auxiliary treatment for fresh colds, 1 teaspoonful in a half glass of hot water or milk, will help to stimulate the circulation and increase activity of the pores of the skin, to lessen the chilling and aching and increase the vitality. Taken on retiring, after a hot foot bath, it will help to start perspira- tion. The patient should rest in bed, keeping well covered during and following perspiration and until the fever and aching have stopped. For authoritative information regarding colds and their treatment, 'refer to Rawleigh's Good Health Bulletin, No. 201, 'Influenza and LaGrippe'. [Statements of a similar nature in foreign languages]." On September 4, 1934, the W. T. Rawleigh Co., Minneapolis, Minn., having appeared as claimant for the property and having admitted the allegations of the libel, judgment of condemnation was entered and it was ordered by the court that the products be released to the claimant under bond, conditioned that they be relabeled under the supervision of this Department. M. L. WILSON, Acting Secretary of Agriculture.