The term “labeling” designates all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container.
The term “label” designates that part of the labeling upon the immediate container. A shipping container containing a single article, unless such container is also essentially the immediate container or the outside of the consumer package, is labeled with a minimum of product identification (except for controlled articles), lot number, expiration date, and conditions for storage and distribution. Articles in these compendia are subject to compliance with such labeling requirements as may be promulgated by governmental bodies in addition to the compendial requirements set forth for the articles.
Label: Amount of Ingredient Per Dosage Unit:
The strength of a drug product is expressed on the container label in terms of micrograms or milligrams or grams or percentage of the therapeutically active moiety or drug substance, whichever form is used in the title, unless otherwise indicated in an individual monograph. Both the active moiety and drug substance names and their equivalent amounts are then provided in the labeling. Official articles in capsule, tablet, or other unit dosage form shall be labeled to express the quantity of each active ingredient or recognized nutrient contained in each such unit; except that, in the case of unit-dose oral solutions or suspensions, whether supplied as liquid preparations or as liquid preparations that are constituted from solids upon addition of a designated volume of a specific diluent, the label shall express the quantity of each active ingredient or recognized nutrient delivered under the conditions prescribed in Deliverable Volume 〈698〉. Official drug products not in unit dosage form shall be labeled to express the quantity of each active ingredient in each milliliter or in each gram, or to express the percentage of each such ingredient (see 8.140., Percentage Concentrations), except that oral liquids or solids intended to be constituted to yield oral liquids may, alternatively, be labeled in terms of each 5-mL portion of the liquid or resulting liquid. Unless otherwise indicated in a monograph or chapter, such declarations of strength or quantity shall be stated only in metric units.
Labeling: Use of Leading and Terminal Zeros
To help minimize the possibility of errors in the dispensing and administration of drugs, the quantity of active ingredient when expressed in whole numbers shall be shown without a decimal point that is followed by a terminal zero (e.g., express as 4 mg [not 4.0 mg]). The quantity of active ingredient when expressed as a decimal number smaller than 1 shall be shown with a zero preceding the decimal point (e.g., express as 0.2 mg [not .2 mg]).
Labeling of Salts of Drugs
It is an established principle that official articles shall have only one official title. For purposes of saving space on labels, and because chemical symbols for the most common inorganic salts of drugs are well known to practitioners as synonymous with the written forms, the following alternatives are permitted in labeling official articles that are salts: HCl for hydrochloride; HBr for hydrobromide; Na for sodium; and K for potassium. The symbols Na and K are intended for use in abbreviating names of the salts of organic acids, but these symbols are not used where the word Sodium or Potassium appears at the beginning of an official title (e.g., Phenobarbital Na is acceptable, but Na Salicylate is not to be written).
Labeling Vitamin-Containing Products
The vitamin content of an official drug product shall be stated on the label in metric units per dosage unit. The amounts of vitamins A, D, and E may be stated also in USP Units. Quantities of vitamin A declared in metric units refer to the equivalent amounts of retinol (vitamin A alcohol). The label of a nutritional supplement shall bear an identifying lot number, control number, or batch number. 10.40.50. Labeling Botanical-Containing Products The label of an herb or other botanical intended for use as a dietary supplement bears the statement, “If you are pregnant or nursing a baby, seek the advice of a health professional before using this
Labeling Parenteral and Topical Preparations
The label of a preparation intended for parenteral or topical use states the names of all added substances (see 5.20., Added Substances, Excipients, and Ingredients and see Labeling under Injections 〈1〉), and, in the case of parenteral preparations, also their amounts or proportions, except that for substances added for adjustment of pH or to achieve isotonicity, the label may indicate only their presence and the reason for their addition.
The concentration and dosage of electrolytes for replacement therapy (e.g., sodium chloride or potassium chloride) shall be stated on the label in milliequivalents (mEq). The label of the product shall indicate also the quantity of ingredient(s) in terms of weight or percentage concentration.
The content of alcohol in a liquid preparation shall be stated on the label as a percentage (v/v) of C2H5OH.
Symbols Commonly Employed for SI Metric Unit
Symbols commonly employed for SI metric units and other units
are as follows:
Bq = becquerel dL = deciliter
kBq = kilobecquerel L = liter
MBq = megabecquerel mL = milliliterc
GBq = gigabecquerel μL = microliter
Ci = curie Eq = gram-equivalent weight
mCi = millicurie mEq = milliequivalent
μCi = microcurie mol = gram-molecular weight (mole)
nCi = nanocurie Da = dalton (relative molecular mass)
Gy = gray mmol = millimole
mGy = milligray Osmol = osmole
m = meter mOsmol = milliosmole
dm = decimeter Hz = hertz
cm = centimeter kHz = kilohertz
mm = millimeter MHz = megahertz
μm = micrometer (0.001mm) V = volts
nm = nanometera MeV = million electron volts
kg = kilogram keV = kilo-electron volt
g = gram mV = millivolt
mg = milligram psi = pounds per square inch
μg; mcg = microgramb Pa = pascal
ng = nanogram kPa = kilopascal
pg = pictogram g = gravity (in centrifugation)
fg = femtogram
a Previously the symbol mμ (for millimicron) was used.
b One milliliter (mL) is used herein as the equivalent of one cubic centimeter (cc).
c The symbol μg is used in the USP and NF to represent micrograms, but micrograms
may be represented as “mcg” for labeling and prescribing purposes. The term
“gamma,” symbolized by γ, frequently is used to represent micrograms in biochemical