[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.78]

[Page 242-243]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 341.78  Labeling of expectorant 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 
``expectorant.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' the following: ``Helps loosen phlegm (mucus) 
and thin bronchial secretions to'' (select one or more of the following: 
``rid the bronchial passageways of bothersome mucus,'' ``drain bronchial 
tubes,'' and ``make coughs more productive''). 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.
    (c) Warnings. The labeling of the product contains the following 
warnings, under the heading ``Warnings'':
    (1) ``A persistent cough may be a sign of a serious condition. If 
cough persists for more than 1 week, tends to recur, or is accompanied 
by a fever, rash, or persistent headache, consult a doctor.''
    (2) For expectorant drug products labeled for adults or for adults 
and children under 12 years of age. ``Do not take this product for 
persistent or chronic cough such as occurs with smoking, asthma, chronic 
bronchitis, or emphysema, or where cough is accompanied by excessive 
phlegm (mucus) unless directed by a doctor.''
    (3) For expectorant drug products labeled only for children under 12 
years of age. ``Do not give this product for persistent or chronic cough 
such as occurs with asthma or if cough is accompanied by excessive 
phlegm (mucus) unless directed by a doctor.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'' for products containing 
guaifenesin identified in Sec. 341.18: Adults and children 12 years of 
age and over: oral dosage is 200 to 400 milligrams every 4 hours not to 
exceed 2,400 milligrams in 24 hours. Children 6 to under 12 years of 
age: oral dosage is 100 to 200 milligrams every 4 hours not to exceed 
1,200 milligrams in 24 hours. Children 2 to under 6 years of age: oral 
dosage is 50 to 100 milligrams every 4 hours not to exceed 600 
milligrams in 24 hours. Children under 2 years of age: consult a doctor.
    (e) The word ``physician'' may be substituted for the word 
``doctor'' in any

[[Page 243]]

of the labeling statements in this section.

[54 FR 8509, Feb. 28, 1989, as amended at 57 FR 29177, June 30, 1992]