21 CFR § 341.78 - Labeling of expectorant drug products.

§ 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 § 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 § 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 of the labeling statements in this section.

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

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