[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR338.50]

[Page 234-235]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 338_NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--
 
                           Subpart C_Labeling
 
Sec.  338.50  Labeling of nighttime sleep-aid 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 a 
``nighttime sleep-aid.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' one or more of the phrases listed in this 
paragraph. 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 Sec.  330.1(c)(2) of 
this chapter, 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.
    (1) (``Helps you'' or ``Reduces time to'') ``fall asleep if you have 
difficulty falling asleep.''
    (2) ``For relief of occasional sleeplessness.''
    (3) ``Helps to reduce difficulty falling asleep.''
    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) ``Do not give to children under 12 years of age.''
    (2) ``If sleeplessness persists continuously for more than 2 weeks, 
consult your doctor. Insomnia may be a symptom of serious underlying 
medical illness.''
    (3) ``Do not take this product, unless directed by a doctor, if you 
have a breathing problem such as emphysema or chronic bronchitis, or if 
you have glaucoma or difficulty in urination due to enlargement of the 
prostate gland.''

[[Page 235]]

    (4) ``Avoid alcoholic beverages while taking this product. Do not 
take this product if you are taking sedatives or tranquilizers, without 
first consulting your doctor.''
    (5) ``Do not use [bullet]\1\ with any other product containing 
diphenhydramine, even one used on skin''.
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    \1\ See Sec.  201.66(b)(4) of this chapter for definition of bullet 
symbol.
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    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'':
    (1) For products containing diphenhydramine hydrochloride identified 
in Sec.  338.10(a). Adults and children 12 years of age and over: Oral 
dosage is 50 milligrams at bedtime if needed, or as directed by a 
doctor.
    (2) For products containing diphenhydramine citrate identified in 
Sec.  338.10(b). Adults and children 12 years of age and over: Oral 
dosage is 76 milligrams at bedtime if needed, or as directed by a 
doctor.
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this section.

[54 FR 6826, Feb. 14, 1989, as amended at 59 FR 16983, Apr. 11, 1994; 67 
FR 72559, Dec. 6, 2002]