[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: 21CFR341.76] [Page 248-249] 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 Subpart C_Labeling Sec. 341.76 Labeling of bronchodilator 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 ``bronchodilator.'' (b) Indications. The labeling of the product states, under the heading ``Indications,'' the phrase listed in paragraph (b)(1) of this section. 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), 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) ``For temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma.'' [[Page 249]] (2) In addition to the required information identified in paragraph (b)(1) of this section, the labeling of the product may contain one or more of the following statements: (i) ``For the'' (select one of the following: ``temporary relief'' or ``symptomatic control'') ``of bronchial asthma.'' (ii) ``Eases breathing for asthma patients'' (which may be followed by: ``by reducing spasms of bronchial muscles''). (c) Warnings. The labeling of the product contains the following warnings under the heading ``Warnings'': (1) ``Do not use this product unless a diagnosis of asthma has been made by a doctor.'' (2) ``Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.'' (3) ``Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a doctor.'' (4) Drug interaction precaution. ``Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.'' (5) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in Sec. 341.16 (a), (b), (c), and (f). (i) ``Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 1 hour or become worse.'' (ii) ``Some users of this product may experience nervousness, tremor, sleeplessness, nausea, and loss of appetite. If these symptoms persist or become worse, consult your doctor.'' (6) For products containing epinephrine, epinephrine bitartrate, or racepinephrine hydrochloride identified in Sec. 341.16 (d), (e), and (g). (i) ``Do not use this product more frequently or at higher doses than recommended unless directed by a doctor. [first sentence in boldface type] Excessive use may cause nervousness and rapid heart beat, and, possibly, adverse effects on the heart.'' (ii) ``Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 20 minutes or become worse.'' [sentence in boldface type] (iii) For products intended for use in a hand-held rubber bulb nebulizer. ``Do not use this product if it is brown in color or cloudy.'' (d) Directions. The labeling of the product contains the following information under the heading ``Directions'': (1) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in Sec. 341.16 (a), (b), (c), and (f). Adults and children 12 years of age and over: Oral dosage is 12.5 to 25 milligrams every 4 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Do not exceed recommended dose unless directed by a doctor. Children under 12 years of age: Consult a doctor. (2) For products containing epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride identified in Sec. 341.16(d), (e), and (g) for use in a hand-held rubber bulb nebulizer. The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine. Inhalation dosage for adults, children 12 years of age and over, and children 4 to under 12 years of age: 1 to 3 inhalations not more often than every 3 hours. The use of this product by children should be supervised by an adult. Children under 4 years of age: Consult a doctor. (Collection of information requirement approved by the Office of Management and Budget under control number 0910-0237) [51 FR 35339, Oct. 2, 1986, as amended at 52 FR 7126, Mar. 9, 1987; 52 FR 7830, Mar. 13, 1987; 53 FR 35810, Sept. 15, 1988; 58 FR 54242, Oct. 20, 1993; 61 FR 25146, May 20, 1996; 62 FR 9684, Mar. 4, 1997; 64 FR 13295, Mar. 17, 1999]