• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR340]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE
 
PART 340STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
 

Subpart A - General Provisions

Sec. 340.1 Scope.

(a) An over-the-counter stimulant drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

Sec. 340.3 Definition.

As used in this part:

Stimulant. A drug which helps restore mental alertness or wakefulness during fatigue or drowsiness.

Subpart B - Active Ingredient

Sec. 340.10 Stimulant active ingredient.

The active ingredient of the product consists of caffeine when used within the dosage limits established in § 340.50(d).

Subpart C - Labeling

Sec. 340.50 Labeling of stimulant drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an "altertness aid" or a "stimulant."

(b) Indications. The labeling of the product states, under the heading "Indications," the following: "Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness." Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the Act relating to misbranding and the prohibition in section 301(d) of the Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Act.

(c) Warnings. The labeling of the product contains the following warnings under the heading "Warnings":

(1) "The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat."

(2) "For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a" (select one of the following: "physician" or "doctor").

(3) "Do not give to children under 12 years of age."

(d) Directions. The labeling of the product contains the following information under the heading "Directions": Adults and children 12 years of age and over: Oral dosage is 100 to 200 milligrams not more often than every 3 to 4 hours.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 53 FR 6105, Feb. 29, 1988, unless otherwise noted.

-
-