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and mouth. Applications may be repeated up to three times daily or as directed by a doctor. Children under 2 years of age: consult a doctor.

(iii) For products containing menthol identified in §341.14(b)(2) in a lozenge. The product contains 5 to 10 milligrams menthol. Adults and children 2 to under 12 years of age: Allow lozenge to dissolve slowly in the mouth. May be repeated every hour as needed or as directed by a doctor. Children under 2 years of age: Consult a doctor.

(iv) For products containing camphor identified in § 341.14(b)(1) for steam inhalation use. The product contains 6.2 percent camphor. Adults and children 2 to under 12 years of age: Add 1 tablespoonful of solution, for each quart of water, directly to the water in a hot steam vaporizer, bowl, or wash basin; or add 11⁄2 teaspoonsful of solution, for each pint of water, to an open container of boiling water. Breathe in the medicated vapors. May be repeated up to three times daily or as directed by a doctor. Children under 2 years of age: consult a doctor.

(v) For products containing menthol identified in § 341.14(b)(2) for steam inhalation use. The product contains 3.2 percent menthol. Adults and children 2 to under 12 years of age: Add 1 tablespoonful of solution, for each quart of water, directly to the water in a hot steam vaporizer, bowl, or wash basin; or add 11⁄2 teaspoonsful of solution, for each pint of water, to an open container of boiling water. Breathe in the medicated vapors. May be repeated up to three times daily or as directed by a doctor. 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.

(f) Exemption from the general accidental overdose warning. The labeling for antitussive drug products containing the active ingredient identified in §341.14(b)(2) marketed in accordance with §341.74(d)(2)(iii) is exempt from the requirement in §330.1(g) of this chapter that the labeling bear the general warning statement "In case of accidental overdose, seek professional assistance or contact a poison control center immediately." The labeling

must continue to bear the first part of the general warning in §330.1(g) of this chapter, which states, "Keep this and all drugs out of the reach of children."

[52 FR 30055, Aug. 12, 1987; 52 FR 35610, Sept. 22, 1987; 53 FR 35809, Sept. 15, 1988; 55 FR 27808, July 6, 1990; 55 FR 40383, Oct. 3, 1990; 58 FR 54236, Oct. 20, 1993; 59 FR 29174, June 3, 1994; 59 FR 36051, July 15, 1994]

of bronchodilator

§ 341.76 Labeling of 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 §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.'

(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 this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.”

(5) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 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 § 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 $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 § 341.16(d), (e), and (g) for use in a handheld 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]

§ 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]

§ 341.80 Labeling of nasal decongestant 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 "nasal decongestant."

(b) Indications. The labeling of the product states, under the heading "Indications," the phrase listed in paragraph (b)(1) of this section, as appropriate, and may contain any additional phrases listed in paragraph (b)(2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been

established and listed in paragraphs (b)(1) and (b)(2) of this section, may also be used, as provided in §330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (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) (Select one of the following: "For the temporary relief of nasal congestion" or "Temporarily relieves nasal congestion") (which may be followed by any of the following in paragraphs (b)(1) (i), (ii), and (iii) of this section): (i) “due to" (select one of the following: "the common cold" or "a cold”).

(ii) “due to” (select one of the following: "hay fever," "hay fever (allergic rhinitis)," "hay fever or other upper respiratory allergies," or "hay fever or other upper respiratory allergies (allergic rhinitis)”).

(iii) "associated with sinusitis.”

(2) In addition to the information identified in paragraph (b)(1) of this section, the labeling of the product may contain any (one or more) of the following statements:

(i) (Select one of the following: "For the temporary relief of" or "Temporarily relieves") (select one of the following: "stuffy nose," "stopped up nose," "nasal stuffiness," or "clogged up nose.")

(ii) (Select one of the following: "Reduces swelling of," "Decongests," or "Helps clear”) “nasal passages; shrinks swollen membranes.”

(iii) "Temporarily restores freer breathing through the nose.

(iv) "Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure."

(v) "Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure."

(c) Warnings. The labeling of the product contains the following warnings under the heading "Warnings":

(1) Oral nasal decongestants-(i) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, or pseudoephedrine sulfate identified in § 341.20 (a)(1), (a)(2), and (a)(3) when labeled for adults. (A) “Do not exceed

recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor."

(B) "If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor."

(C) "Do not take 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."

(D) "Drug interaction precaution. Do not use this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product."

(ii) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, or pseudoephedrine sulfate identified in $341.20 (a)(1), (a)(2), and (a)(3) when labeled for children under 12 years of age. (A) "Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor."

(B) "If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor."

(C) "Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor."

(D) "Drug interaction precaution. Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child's prescription drug contains an MAOI, consult a health professional before giving this product."

(iii) For oral nasal decongestant products labeled for both adults and children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(1)(i) of this section.

(2) Topical nasal decongestants—(i) For products containing any topical nasal decongestant identified in $341.20(b) when labeled for adults. (A) "Do not exceed recommended dosage." [sentence in boldface type]

(B) "This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge."

(C) "The use of this container by more than one person may spread infection."

(ii) [Reserved]

(iii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in §341.20 (b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for adults. (A) "Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor."

(B) "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."

(iv) For products containing naphazoline hydrochloride identified in $341.20(b)(6) at a concentration of 0.05 percent. "Do not use this product in children under 12 years of age because it may cause sedation if swallowed.”

(v) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”

(vi) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(2)(i) of this section.

(vii) [Reserved]

(viii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride,

oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in §341.20(b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for children under 12 years of age. (A) "Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor."

(B) "Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”

(ix) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for children under 12 years of age. "Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor."

(x) For topical nasal decongestant products labeled for both adults and for children under 12 years of age. The labeling of the product contains the applicable warnings identified in paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), and (c)(2)(v) of this section.

(d) Directions. The labeling of the product contains the following information under the heading "Directions":

(1) Oral nasal decongestants—(i) For products containing phenylephrine hydrochloride identified in § 341.20(a)(1). Adults and children 12 years of age and over: 10 milligrams every 4 hours not to exceed 60 milligrams in 24 hours. Children 6 to under 12 years of age: 5 milligrams every 4 hours not to exceed 30 milligrams in 24 hours. Children 2 to under 6 years of age: 2.5 milligrams every 4 hours not to exceed 15 milligrams in 24 hours. Children under 2 years of age: consult a doctor.

(ii) For products containing pseudoephedrine hydrochloride or pseudoephedrine sulfate identified in § 341.20 (a)(2) and (a)(3). Adults and children 12 years of age and over: 60 milligrams every 4 to 6 hours not to exceed 240 milligrams in 24 hours. Children 6 to under 12 years of age: 30 milligrams every 4 to 6 hours not to exceed 120

milligrams in 24 hours. Children 2 to under 6 years of age: 15 milligrams every 4 to 6 hours not to exceed 60 milligrams in 24 hours. Children under 2 years of age: consult a doctor.

(2) Topical nasal decongestants—(i) [Reserved]

(ii) For products containing ephedrine, ephedrine hydrochloride, or ephedrine sulfate identified in §341.20(b) (2), (3), and (4)—(A) Nasal drops or sprays—For a 0.5-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Children 6 to under 12 years of age (with adult supervision): 1 or 2 drops or sprays in each nostril not more often than every 4 hours. Children under 6 years of age: consult a doctor.

(B) Nasal jelly-For a 0.5-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours.

(iii) For products containing naphazoline hydrochloride identified in §341.20(b)(6)—(A) Nasal drops or sprays— (1) For a 0.05-percent aqueous solution. Adults and children 12 years of age and over: 1 or 2 drops or sprays in each nostril not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.

(2) For a 0.025-percent aqueous solution. Children 6 to under 12 years of age (with adult supervision): 1 or 2 drops or sprays in each nostril not more often than every 6 hours. Children under 6 years of age: consult a doctor.

(B) Nasal jelly—(1) For a 0.05-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.

(2) For a 0.025-percent water-based jelly. Children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 6 hours. Children under 6 years of age: consult a doctor.

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