Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “bronchodilator.”

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) 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 relating to misbranding and the prohibition in section 301(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) of the Federal Food, Drug, and Cosmetic Act.

1 See § 201.66(b)(4) of this chapter for the definition of “bullet.”

Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:

The following statements shall appear after the subheading “Do not use” [in bold type]:

“[Bullet] unless a doctor said you have asthma”.

“[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.”

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”.

The following information shall appear after the subheading “Ask a doctor or pharmacist before use if you are” [in bold type]:

“[Bullet] taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions”.

“[Bullet] taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)”.

The following information shall appear after the subheading “When using this product” [in bold type]:

“[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]

“[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]

“[Bullet] avoid foods or beverages that contain caffeine”.

“[Bullet] avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect”.

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]:

“[Bullet] are not better in 60 minutes”.

“[Bullet] get worse”.

“[Bullet] need more than [insert total number of dosage units that equals 150 milligrams] in 24 hours”.

“[Bullet] use more than [insert total number of dosage units that equals 100 milligrams] in 24 hours for 3 or more days a week”.

“[Bullet] have more than 2 asthma attacks in a week”.

“These may be signs that your asthma is getting worse.”

“[Bullet] This product will not give you asthma relief as quickly as an inhaled bronchodilator.”

This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings”.

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]:

“[Bullet] are not better in 20 minutes”.

“[Bullet] get worse”.

“[Bullet] need more than 12 inhalations in 24 hours”.

“[Bullet] use more than 9 inhalations in 24 hours for 3 or more days a week”.

“[Bullet] have more than 2 asthma attacks in a week”.

“These may be signs that your asthma is getting worse.”

This “Asthma alert” shall appear on any labeling that contains warnings and shall be the first warning statement under the heading “Warnings.”

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) of this section: “[bullet] if product is brown in color or cloudy”.

The following information shall appear after the subheading “Stop use and ask a doctor if” [in bold type]:

“[Bullet] your asthma is getting worse (see Asthma alert)”.

“[Bullet] you have difficulty sleeping”.

“[Bullet] you have a rapid heart beat”.

“[Bullet] you have tremors, nervousness, or seizure”.

Directions. The labeling of the product contains the following information under the heading “Directions”:

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]

“[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”.

“[Bullet] children under 12 years of age: ask a doctor”.

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:

“[Bullet] do not use more than directed” [appears as first bulleted statement under “Directions” and in bold type].

“[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.”

“[Bullet] children under 4 years of age: ask a doctor”.