[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: 21CFR341.3]

[Page 228-229]
 
                        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 A--General Provisions
 
Sec. 341.3  Definitions.

    As used in this part:
    (a) Bronchodilator drug. A drug used to overcome spasms that cause 
narrowing of the bronchial air tubes, such as in the symptomatic 
treatment of the wheezing and shortness of breath of asthma.

[[Page 229]]

    (b) Oral antitussive drug. A drug that either is taken by mouth or 
is dissolved in the mouth in the form of a lozenge and acts systemically 
to relieve cough.
    (c) Topical antitussive drug. A drug that relieves cough when 
inhaled after being applied topically to the throat or chest in the form 
of an ointment or from a steam vaporizer, or when dissolved in the mouth 
in the form of a lozenge for a local effect.
    (d) Expectorant drug. A drug taken orally to promote or facilitate 
the removal of secretions from the respiratory airways.
    (e) Antihistamine drug. A drug used for the relief of the symptoms 
of hay fever and upper respiratory allergies (allergic rhinitis).
    (f) Oral nasal decongestant drug. A drug that is taken by mouth and 
acts systemically to reduce nasal congestion caused by acute or chronic 
rhinitis.
    (g) Topical nasal decongestant drug. A drug that when applied 
topically inside the nose, in the form of drops, jellies, or sprays, or 
when inhaled intranasally reduces nasal congestion caused by acute or 
chronic rhinitis.
    (h) Calibrated dropper. A dropper calibrated such that the volume 
error incurred in measuring any liquid does not exceed 15 percent under 
normal use conditions.

[51 FR 35339, Oct. 2, 1986, as amended at 54 FR 8509, Feb. 28, 1989; 55 
FR 40382, Oct. 3, 1990; 57 FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, 
1994]