---
kind: "section"
citation: "21 C.F.R. § 341.76"
title: "21"
number: "341.76"
heading: "Labeling of bronchodilator drug products."
url: "https://uscodex.org/cfr/21/341.76"
---

# §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) **Indication.** The labeling of the product states the following under the heading “Use”: “for temporary relief of mild symptoms of intermittent asthma: [bullet] 1 wheezing [bullet] tightness of chest [bullet] shortness of breath”. Other truthful and nonmisleading statements, describing only the indication for use that has been established and listed in this [paragraph (b)](#b) may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the Federal Food, Drug, and Cosmetic Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=a) of the Federal Food, Drug, and Cosmetic Act.
- (c) **Warnings.** The labeling of the product contains the following warnings under the heading “Warnings”:
  - (1) The following statements shall appear after the subheading “Do not use” [in bold type]:
    - (i) “[Bullet] unless a doctor said you have asthma”.
    - (ii) “[Bullet] if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken 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.”
  - (2) The following information shall appear after the subheading “Ask a doctor before use if you have” [in bold type]: “[bullet] ever been hospitalized for asthma [bullet] heart disease [bullet] high blood pressure [bullet] diabetes [bullet] thyroid disease [bullet] seizures [bullet] narrow angle glaucoma [bullet] a psychiatric or emotional condition [bullet] trouble urinating due to an enlarged prostate gland”.
  - (3) The following information shall appear after the subheading “Ask a doctor or pharmacist before use if you are” [in bold type]:
    - (i) “[Bullet] taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions”.
    - (ii) “[Bullet] taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)”.
  - (4) The following information shall appear after the subheading “When using this product” [in bold type]:
    - (i) “[Bullet] your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.” [in bold type]
    - (ii) “[Bullet] your risk of heart attack or stroke increases if you: [Bullet] have a history of high blood pressure or heart disease [Bullet] take this product more frequently or take more than the recommended dose”. [in bold type]
    - (iii) “[Bullet] avoid foods or beverages that contain caffeine”.
    - (iv) “[Bullet] avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect”.
  - (5) **For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16(a), (b), (c), and (f).**
    - (i) The following information shall appear after the subheading “Asthma alert: Because asthma may be life threatening, see a doctor if you” [in bold type]:
      - (A) “[Bullet] are not better in 60 minutes”.
      - (B) “[Bullet] get worse”.
      - (C) “[Bullet] need more than [insert total number of dosage units that equals 150 milligrams] in 24 hours”.
      - (D) “[Bullet] use more than [insert total number of dosage units that equals 100 milligrams] in 24 hours for 3 or more days a week”.
      - (E) “[Bullet] have more than 2 asthma attacks in a week”.
      - (F) “These may be signs that your asthma is getting worse.”
      - (G) “[Bullet] This product will not give you asthma relief as quickly as an inhaled bronchodilator.”
    - (ii) This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings”.
  - (6) **For products containing epinephrine, epinephrine bitartrate, or racepinephrine hydrochloride identified in § 341.16(d), (e), and (g).**
    - (i) The following information shall appear after the subheading “Asthma alert: Because asthma may be life threatening, see a doctor if you” [in bold type]:
      - (A) “[Bullet] are not better in 20 minutes”.
      - (B) “[Bullet] get worse”.
      - (C) “[Bullet] need more than 12 inhalations in 24 hours”.
      - (D) “[Bullet] use more than 9 inhalations in 24 hours for 3 or more days a week”.
      - (E) “[Bullet] have more than 2 asthma attacks in a week”.
      - (F) “These may be signs that your asthma is getting worse.”
    - (ii) This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings.”
    - (iii) **For products intended for use in a hand-held rubber bulb nebulizer.** The following statement shall also appear after the subheading “Do not use” along with the other information in [paragraph (c)(1)](#c-1) of this section: “[bullet] if product is brown in color or cloudy”.
  - (7) The following information shall appear after the subheading “Stop use and ask a doctor if” [in bold type]:
    - (i) “[Bullet] your asthma is getting worse (see Asthma alert)”.
    - (ii) “[Bullet] you have difficulty sleeping”.
    - (iii) “[Bullet] you have a rapid heart beat”.
    - (iv) “[Bullet] you have tremors, nervousness, or seizure”.
- (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)—**
    - (i) “[Bullet] do not take more than directed” [sentence appears as first bulleted statement under “Directions” and in bold type]
    - (ii) “[Bullet] adults and children 12 years of age and over: oral dose is 12.5 to 25 milligrams every 4 hours as needed. Do not take more than 150 milligrams in 24 hours”.
    - (iii) “[Bullet] children under 12 years of age: ask a doctor”.
  - (2) **For products containing epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride identified in § 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:
    - (i) “[Bullet] do not use more than directed” [appears as first bulleted statement under “Directions” and in bold type].
    - (ii) “[Bullet] adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours. Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult.”
    - (iii) “[Bullet] children under 4 years of age: ask a doctor”.

## Notes

### Amendments

[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; 76 FR 44487, July 26, 2011]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Amendments

[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; 76 FR 44487, July 26, 2011]