Paregoric, or camphorated tincture of opium, also known as tinctura opii camphorata, is a patent medicine known for its antidiarrheal, antitussive, and analgesic properties. According to Goodman and Gilman's 1965 edition, "Paregoric is a 4% opium tincture in which there is also benzoic acid, camphor, and anise oil. ... Paregoric by tradition is used especially for children."Goodman and Gilman, Pharmacological basis of therapeutics, Macmillan 1965, p. 261.
The term paregoric, which comes from Ancient Greek parēgorikós "soothing", has also been used for boiled sweets which contained the substance, in particular the Army & Navy brand.
Properties In 1944, two clinicians who evaluated the expectorant action of paregoric, concluded:
The survival of paregoric through the centuries, and particularly through recent critical decades, is probably due to keen clinical observation and stubborn adherence to the clinical deduction that paregoric is useful in certain types of cough.
History In the early 18th century, Jakob Le Mort (1650–1718), a professor of chemistry at Leiden University, prepared an elixir for asthma and called it "paregoric". The word "paregoric" comes from the Greek word "paregoricon" which was originally applied to oratory – to speak, but, more accurately, talk over, soothe, and finally came to have the same meaning as "anodyne". Le Mort's elixir, consisting of "honey, licorice, flowers of Benjamin, and opium, camphor, oil of aniseed, salt of tartar and spirit of wine", appears as "Elixir Asthmaticum" in the London Pharmacopoeia of 1721. Its ingredients were assembled according to the humoral theory of the time. Paregoric was used in various formulations for hundreds of years.
Paregoric was a household remedy in the 18th and 19th centuries when it was widely used to control diarrhea in adults and children, as an expectorant and cough medicine, to calm fretful children, and to rub on the gums to counteract the pain from teething. In a memoir of life in Mississippi after the American Civil War, one woman recalled, "I wonder how any of us grew up, the drinking water of the village was so contaminated...All the family was subject to violent attacks of stomach and intestinal trouble. These were called cramp colic, cholera, morbus flux, etc., and no one ever dreamed of connecting them with the drinking supply. My father had a medicine chest filled with paregoric, Jamaica ginger and cholera mixture, which he dispersed freely."
A formula for paregoric from Dr. Chase's Recipes (1865):
A dram (dr.) is about 1.8 grams, a modern teaspoon is 5 mL, and a scruple is teaspoon.
The Medical Companion, Or Family Physician, a book from 1827, gave the following recipe:
Use during the 20th century During the 20th century its use declined as governments regulated its ingredients (opium is a controlled substance in many countries). Beginning in late 2011, there was a period in which paregoric was not being manufactured in the United States. , however, the manufacture of paregoric had resumed.
Regulation The early 20th century brought increased regulation of all manner of narcotics, including paregoric, as the addictive properties of opium became more widely understood, and "patent medicines came under fire largely because of their mysterious compositions".In the Arms of Morpheus: The Tragic History of Laudanum, Morphine, and Patent Medicines," by Barbara Hodgson. Buffalo, New York: Firefly Books, 2001, page 126. In the United States, the Pure Food and Drug Act of 1906 required that certain specified drugs, including alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels. Cocaine, heroin, cannabis, and other such drugs continued to be legally available without prescription as long as they were labeled. It is estimated that sale of patent medicines containing opiates decreased by 33% after labeling was mandated. In 1906 in Britain and in 1908 in Canada laws requiring disclosure of ingredients and limitation of narcotic content were instituted.
The U.S. Harrison Narcotics Tax Act of 1914 restricted the manufacture and distribution of opiates, including laudanum and coca derivatives; this was followed by France's Loi des stupefiants in 1916 and Britain's Dangerous Drugs Act in 1920. The Harrison Narcotics Tax ActThe Harrison Narcotics Act (Public Law 63-223, December 17, 1914) was named for its sponsor, Sen. Francis Burton Harrison (1873–1957) regulated "opium or coca leaves, or any compound, manufacture, salt, derivative or preparation thereof", but not some medical products containing relatively low concentrations of these substances.According to one source, the 1914 Act "profoundly changed the nature of the narcotics problem in the United States. This law was intended as a revenue and control measure and was not designed to penalize the user of the drug, to whom no direct reference was made. The enforcement of the law was entrusted to the Bureau of Internal Revenue of the U.S. Treasury Department. It was evidently assumed or hoped that by requiring all persons who handled drugs to register with the government and maintain records the flow of drugs would be subject to public control. The act applied equally to cocaine and to opiates and made no distinctions between them. It required all persons who imported, manufactured, produced, compounded, sold, dealt in, dispensed, or gave away any derivative of opium or of coca leaves (cocaine) to register with the Collector of Internal Revenue, to pay special taxes, and to keep records of their transactions. Preparations containing minute quantities of cocaine or of opiates were exempted from the regulations." (See drugtext.org, visited February 6, 2008 ). Paregoric was classified as an "Exempt Narcotic", as were other medical products containing small amounts of opium or their derivatives.Section 6 of the 1914 Act did not apply "to the sale, distribution, giving away, dispensing or possession of preparations and remedies which do not contain more than two grains of opium, or more than one-fourth of a grain of morphine, or more than one-eighth of grain of heroin, or more than one grain of codeine, or any salt or derivative of them, in one fluid ounce, or, if a solid or semisolid preparation, in one avoirdupois ounce; or to liniments, ointments, or other preparations which are prepared for external use only, except liniments, ointments, or other preparations which contain cocaine or any of its salts."
Regulation and use since 1970 Until 1970, paregoric could be purchased in the United States at a pharmacy without a medical prescription, in accordance with federal law. Federal law dictated that no more than two ounces of paregoric be dispensed by any pharmacy to the same purchaser within a 48-hour period. Purchasers were also required to sign a register or logbook, and pharmacies were technically required to request identification from any purchaser not personally known to the pharmacist. Some states further limited the sale of paregoric or banned over-the-counter sales entirely. For example, Michigan law disallowed over-the-counter (OTC) sale of paregoric in April 1964 but still allowed OTC sales of certain exempt cough medication preparations that contain 60 mg of codeine per fluid ounce. Even where legally permissible by law, OTC sale of paregoric was subject to the discretion of individual pharmacists.
In 1970, paregoric was classified as a Schedule III drug under the Controlled Substances Act; however, drugs that contained a mixture of kaolin, pectin, and paregoric (e.g., Donnagel-PG, Parepectolin, and their generic equivalents) were classified as Schedule V drugs. They were available over-the-counter without a prescription in many states until the early 1990s, at which time the FDA banned the sale of anti-diarrheal drugs containing kaolin and pectin; also, Donnagel-PG contained tincture of belladonna, which became prescription-only on January 1, 1993. Paregoric is currently listed in the United States Pharmacopeia. Manufacture of the drug was discontinued for several months beginning in late 2011; however, production and distribution resumed in 2012, so the drug is still available in the United States by prescription. Thus, it is unclear as to whether the lapse in manufacture actually resulted in a shortage of the drug at any time, since prescription drugs are often still available for many months after manufacture has been discontinued. In France, paregoric was available without prescription until 1986; nowadays, it is used to wean infants born to opiate-addicted women.
Paregoric, U.S.P. formula The principal active ingredient in paregoric is powdered opium. In the United States the formula for Paregoric U.S.P. is a tincture of opium 40 mL, anise oil 4 mL, benzoic acid 4 g, camphor 4 g, glycerin 40 mL, alcohol 450 mL, purified water 450 mL, diluted with alcoholDiluted alcohol is a mixture of equal portions of purified water and 190 proof alcohol (95% alcohol by volume). to 1000 mL, and contains the equivalent of 0.4 mg/mL of anhydrous morphine; one ounce of paregoric contains 129.6 mg (2 grains) of powdered opium, or the equivalent of 13 mg of anhydrous morphine.The Extra Pharmacoepia Martindale, Vol. 1, 24th Edition. London: The Pharmaceutical Press, 1958, p. 924. Describes its preparation as follows: "Dissolve the benzoic acid, camphor and oil of anise in the alcohol, add the glycerin and then the water, very slowly and in divided portions, agitating after each addition. Lastly add the tinct. opii deod. and filter through paper, returning the first portions if necessary until clear. When the liquid ceases to drop from the funnel pass enough diluted alcohol through the filter to make the finished product measure one thousand cubic centimeters." The average adult dose is 4 mL by mouth which corresponds to 16 mg of opium, or 1.6 mg of anhydrous morphine.
It is unclear when the current formula for Paregoric, U.S.P. was developed in the United States. One formula for "Camphorated Tincture of Opium (Paregoric Elixir)" attributed to the United States Pharmacoepia of 1863 is: "Macerate 1 drachm each powdered opium and benzoic acid, 1 fluid drachm of anise, 2 ounces clarified honey, and 2 scruples camphor, in 2 pints diluted alcohol for 7 days, and filter through paper."Encyclopedia of Practical Receipts and Processes, by William B. Dick. 5th edition. New York: Dick & Fitzgerald, Publishers, 1890, p. 416. The Dictionary lists a number of formulas for other opium-based tinctures and compounds, such as: Ammoniated Tincture of Opium, Squibb's Compound Tincture of Opium, Dover's Tincture, McMunn's Elixir of Opium, Murphy's Carminative, Oil of Opium, Battley's Sedative Solution of Opium, and Eisenmann's Opiated Wine of Colchicum. A slightly different formula is given in the 1926 pharmacoepia.The 1926 formula is 4 g each of powdered opium, benzoic acid, and camphor; and 5 of oil of anise, prepared as a tincture by "macerating the ingredients in a mixture of 40 cc of glycerin and 950 cc of diluted alcohol, completing the preparation with diluted alcohol." Source: The Pharmacoepia of the United States of America, 10th Decennial revision (U.S.P. X), official from January 1, 1926. Philadelphia: J. B. Lippincott Company, 1925, p. 401.
The current formula for Paregoric, U.S.P. should not be assumed to be universal. For example, in the United Kingdom the formula for Paregoric, B.P. is tincture of opium 5 mL, benzoic acid 500 mg, camphor 300 mg, anise oil 0.3 mL, alcohol (60%) to 100 mL, and contains about 1/30th grain of anhydrous morphine in 60 minims, which is 25% stronger than Paregoric, U.S.P.
Dosage