(a) The term “alcohol” is defined to mean common or ethyl alcohol. No other kind of alcohol is permissible in the manufacture of drugs except as specified in the United States Pharmacopœia or National Formulary.
(b) The words alcohol, morphin, opium, etc., and the quantities and proportions thereof, shall be printed in letters corresponding in size with those prescribed in [Regulation 17], paragraph (c).
(c) A drug, or food product except in respect of alcohol, is misbranded in case it fails to bear a statement on the label of the quantity or proportion of any alcohol, morphin, opium, heroin, cocain, alpha or beta eucain, chloroform, cannabis indica, chloral hydrate, or acetanilid, or any derivative or preparation of any such substances contained therein.
(d) A statement of the maximum quantity or proportion of any such substances present will meet the requirements, provided the maximum stated does not vary materially from the average quantity or proportion.
(e) In case the actual quantity or proportion is stated it shall be the average quantity or proportion with the variations noted in [Regulation 29].
(f) The following are the principal derivatives and preparations made from the articles which are required to be named upon the label:
- Alcohol, Ethyl (Cologne spirits, Grain alcohol, Rectified spirits, Spirits, and Spirits of wine):
- Derivatives—
- Aldehyd, Ether, Ethyl acetate, Ethyl nitrite, and Paraldehyd.
- Preparations containing alcohol—
- Bitters, Brandies, Cordials, Elixirs, Essences, Fluidextracts, Spirits, Sirups, Tinctures, Tonics, Whiskies, and Wines.
- Morphin, Alkaloid:
- Derivatives—
- Apomorphin, Dionin, Peronin, Morphin acetate, Hydrochlorid, Sulfite, and other salts of morphin.
- Preparations containing morphin or derivatives of morphin—
- Bougies, Catarrh Snuff, Chlorodyn, Compound powder of morphin, Crayons, Elixirs, Granules, Pills, Solutions, Sirups, Suppositories, Tablets, Triturates, and Troches.
- Opium Gum:
- Preparations of Opium—
- Extracts, Denarcotized opium, Granulated opium, and Powdered opium, Bougies, Brown mixture, Carminative mixtures, Crayons, Dover’s powder, Elixirs, Liniments, Ointments, Paregoric, Pills, Plasters, Sirups, Suppositories, Tablets, Tinctures, Troches, Vinegars, and Wines.
- Derivatives—
- Codein, Alkaloid, Hydrochlorid, Phosphate, Sulphate, and other salts of codein.
- Preparations containing codein or its salts—
- Elixirs, Pills, Sirups, and Tablets.
- Cocain, Alkaloid:
- Derivatives—
- Cocain hydrochlorid, Oleate, and other salts.
- Preparations containing cocain or salts of cocain—
- Coca leaves, Catarrh powders, Elixirs, Extracts, Infusion of coca, Ointments, Paste pencils, Pills, Solutions, Sirups, Tablets, Tinctures, Troches, and Wines.
- Heroin:
- Preparations containing heroin—
- Sirups, Elixirs, Pills, and Tablets.
- Alpha and Beta Eucain:
- Preparations—
- Mixtures, Ointments, Powders, and Solutions.
- Chloroform:
- Preparations containing chloroform—
- Chloranodyn, Elixirs, Emulsions, Liniments, Mixtures, Spirits, and Sirups.
- Cannabis Indica:
- Preparations of cannabis indica—
- Corn remedies, Extracts, Mixtures, Pills, Powders, Tablets, and Tinctures.
- Chloral Hydrate (Chloral, U. S. Pharmacopœia, 1890):
- Derivatives—
- Chloral acetophenonoxim, Chloral alcoholate, Chloralamid, Chloralimid, Chloral orthoform, Chloralose, Dormiol, Hypnal, and Uraline.
- Preparations containing chloral hydrate or its derivatives—
- Chloral camphorate, Elixirs, Liniments, Mixtures, Ointments, Suppositories, Sirups, and Tablets.
- Acetanilid (Antifebrin, Phenylacetamid):
- Derivatives—
- Acetphenetidin, Citrophen, Diacetanilid, Lactophenin, Methoxy-acetanilid, Methylacetanilid, Para-Iodoacetanilid, and Phenacetin.
- Preparations containing acetanilid or derivatives—
- Analgesics, Antineuralgics, Antirheumatics, Cachets, Capsules, Cold remedies, Elixirs, Granular effervescing salts, Headache powders, Mixtures, Pain remedies, Pills, and Tablets.
Regulation 29. Statement of Weight or Measure.
(Section 8. Third under “Foods.”)
(a) A statement of the weight or measure of the food contained in a package is not required. If any such statement is printed, it shall be a plain and correct statement of the average net weight or volume, either on or immediately above or below the principal label, and of the size of letters specified in [Regulation 17].