Sample label for drug product.
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[Name of product.] | COUGH SYRUP. |
| |
[Declarations required by | ALCOHOL, 10 PERCENT. |
paragraphs 2 and 3.] | MORPHIN, 1/2 GRAIN PER |
| OUNCE. |
| CHLOROFORM, 40 MINIMS |
| PER OUNCE. |
| |
| [Descriptive matter, if desired, but |
| preferably at bottom of label.] |
| |
[Name of manufacturer, if | JOHN JONES & CO., |
given.] | |
[Place of manufacture, if | WASHINGTON, D. C. |
given.] | |
| [Descriptive matter, if desired.] |
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Any descriptive or explanatory matter that may appear on the principal label, therefore, should be placed at the bottom of the label, or between No. 3 and No. 4, and should be clearly separated from other features of the label by means of a suitable line or space. Statements regarding the reason for using alcohol, artificial coloring matter, and other extraneous substances, come under the head of descriptive or explanatory matter, and should not be interspersed with the declarations required under Nos. 2 and 3.
The information called for under No. 3 should be so worded as to give only the required information, as, for example, "alcohol 17 percent" or "artifically colored." All numbers used in expressing quantity or proportion of substances required to be stated (see Regulation 28) should be expressed in the Arabic notation.
Each substance required to be declared under No. 3 should be printed on a separate line and in type specified in Regulation 17 (c).
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 18, 1907.
(F. I. D. 53.)
FORMULA ON THE LABEL OF DRUGS.
Many inquiries are received relative to the necessity of giving the formula of medicinal remedies on the label. The following is typical:
I should like to know if it will be necessary for me to state on a label the name of the
products from which I prepare my proprietary medicine in order to conform with the
pure food and drugs act. If I do this, it will prohibit me from manufacturing and selling
a remedy which is a secret of my own; and anyone buying it could, from the label, tell
what ingredients were used in its preparation and make his own supply of this medicine.
How does the United States Government expect to protect those who have secret medicinal
preparations they wish to sell at a profit? If the Pure Food Commission desires,
I will send them a sample bottle of my medicine for their inspection and approval.
The food and drugs act, June 30, 1906, does not require the formula of drug products
to be given on the label, but requires only that the quantity or proportion of the ingredients
