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Subpart C-Labeling

338.50 Labeling of nighttime sleep-aid drug

products.

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

SOURCE: 54 FR 6826, Feb. 14, 1989, unless otherwise noted.

Subpart A-General Provisions

years of age: Oral dosage is 25 to 50 milligrams every 6 to 8 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Oral dosage is 12.5 to 25 milligrams every 6 to 8 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor.

(3) For products containing diphenhydramine hydrochloride identified in $336.10(c). Adults and children 12 years of age and over: Oral dosage is 25 to 50 milligrams every 4 to 6 hours, not to exceed 300 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor.

(4) For products containing meclizine hydrochloride identified in $ 336.10(d). Adults and children 12 years of age and over: Oral dosage is 25 to 50 milligrams once daily, or as directed by a doctor.

(e) The word "physician" may be substituted for the word “doctor" in any of the labeling statements in this section.

8338.1 Scope.

(a) An over-the-counter nighttime sleep-aid drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in $330.1 of this chapter.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

(52 FR 15892, Apr. 30, 1987, as amended at 53 FR 35809, Sept. 15, 1988; 59 FR 16982, Apr. 11, 1994]

8338.3 Definition.

As used in this part:

Nighttime sleep-aid. A drug that is useful for the relief of occasional sleeplessness by individuals who have difficulty falling asleep.

8336.80 Professional labeling.

The labeling provided to health professionals (but not to the general public) may contain the following additional indications.

(a) For products containing cyclizine hydrochloride, dimenhydrinate, and diphenhydramine hydrochloride identified in § 336.10 (a), (b), and (c). "For the treatment of vertigo of motion sickness."

(b) For products containing meclizine hydrochloride identified in $336.10(d). “For the treatment of vertigo."

Subpart B-Active Ingredients 8338.10 Nighttime sleep-aid active in

gredients. The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in $338.50(d):

(a) Diphenhydramine hydrochloride. (b) Diphenhydramine citrate.

PART 338-NIGHTTIME SLEEP-AID

DRUG PRODUCTS FOR OVER-THECOUNTER HUMAN USE

Subpart A-General Provisions

Subpart C-Labeling § 338.50 Labeling of nighttime sleep

aid 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 “nighttime sleep-aid."

(b) Indications. The labeling of the product states, under the heading “Indications,” one or more of the phrases listed in this paragraph. Other truthful and nonmisleading statements, describing only the indications for use

Sec. 338.1 Scope. 338.3 Definition.

Subpart B-Active Ingredients

338.10 Nighttime sleep-aid active ingredi

of the labeling statements in this section.

(54 FR 6826, Feb. 14, 1989, as amended at 59 FR 16983, Apr. 11, 1994)

PART 340-STIMULANT DRUG

PRODUCTS FOR OVER-THECOUNTER HUMAN USE

Subpart A-General Provisions

Sec. 340.1 Scope. 340.3 Definition.

Subpart B-Active Ingredient

340.10 Stimulant active ingredient.

Subpart C-Labeling

340.50 Labeling of stimulant drug products.

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

SOURCE: 53 FR 6105, Feb. 29, 1988, unless otherwise noted.

Subpart A-General Provisions

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.

(1) (Helps you” or “Reduces time to") "fall asleep if you have difficulty falling asleep."

(2) "For relief of occasional sleeplessness.

(3) “Helps to reduce difficulty falling asleep."

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

(1) “Do not give to children under 12 years of age.

(2) “If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.”

(3) "Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland."

(4) “Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor."

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

(1) For products containing diphenhydramine hydrochloride identified in $ 338.10(a). Adults and children 12 years of age and over: Oral dosage is 50 milligrams at bedtime if needed, or as directed by a doctor.

(2) For products containing diphenhydramine citrate identified in $ 338.10(b). Adults and children 12 years of age and over: Oral dosage is 76 milligrams at bedtime if needed, or as directed by a doctor.

(e) The word “physician” may be substituted for the word “doctor" in any

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Subpart C-Labeling

PART 341-COLD, COUGH, AL

LERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart A-General Provisions

Sec. 341.1 Scope. 341.3 Definitions.

Subpart B-Active Ingredients

341.12 Antihistamine active ingredients. 341.14 Antitussive active ingredients. 341.16 Bronchodilator active ingredients. 341.18 Expectorant active ingredient. 341.20 Nasal decongestant active ingredi

ents.

Subpart C-Labeling

§ 340.50 Labeling of stimulant 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 "altertness aid" or a "stimulant."

(b) Indications. The labeling of the product states, under the heading “Indications," the following: "Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness. " 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(a) 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.

2gs. The labeling of the product contains the following warnings under the heading "Warnings":

(1) “The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat."

(2) "For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a" (select one of the following: "physician" or "doctor'').

(3) “Do not give to children under 12 years of age."

(d) Directions. The labeling of the product contains the following information under the heading "Directions": Adults and children 12 years of age and over: Oral dosage is 100 to 200 milligrams not more often than every 3 to 4 hours.

341.70 Labeling of OTC drug products con

taining ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug

product). 341.72 Labeling of antihistamine drug prod

ucts. 341.74 Labeling of antitussive drug prod

ucts. 341.76 Labeling of bronchodilator drug prod

ucts. 341.78 Labeling of expectorant drug prod

ucts. 341.80 Labeling of nasal decongestant drug

products. 341.90 Professional labeling.

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

Subpart A-General Provisions

8341.1 Scope.

(a) An over-the-counter cold, cough, allergy, bronchodilator, or antiasthmatic drug product in a form suitable for oral, inhalant, or topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in $330.1.

(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

(51 FR 35339, Oct. 2, 1986)

(c) Chlorpheniramine maleate. (d) Dexbrompheniramine maleate. (e) Dexchlorpheniramine maleate. (f) Diphenhydramine citrate. (g) Diphenhydramine hydrochloride. (h) Doxylamine succinate. (i) Phenindamine tartrate. (j) Pheniramine maleate. (k) Pyrilamine maleate. (1) Thonzylamine hydrochloride. (m) Triprolidine hydrochloride.

(57 FR 58374, Dec. 9, 1992, as amended at 59 FR 4218, Jan. 28, 1994)

8341.3 Definitions.

As used in this part:

(a) Bronchodilator drug. A drug used to overcome spasms that cause narrowing of the bronchial air tubes, such as in the symptomatic treatment of the wheezing and shortness of breath of asthma.

(b) Oral antitussive drug. A drug that either is taken by mouth or is dissolved in the mouth in the form of a lozenge and acts systemically to relieve cough.

(c) Topical antitussive drug. A drug that relieves cough when inhaled after being applied topically to the throat or chest in the form of an ointment or from a steam vaporizer, or when dissolved in the mouth in the form of a lozenge for a local effect.

(d) Expectorant drug. A drug taken orally to promote or facilitate the removal of secretions from the respiratory airways.

(e) Antihistamine drug. A drug used for the relief of the symptoms of hay fever and upper respiratory allergies (allergic rhinitis).

(f) Oral nasal decongestant drug. A drug that is taken by mouth and acts systemically to reduce nasal congestion caused by acute or chronic rhinitis.

(g) Topical nasal decongestant drug. A drug that when applied topically inside the nose, in the form of drops, jellies, or sprays, or when inhaled intranasally reduces nasal congestion caused by acute or chronic rhinitis.

(h) Calibrated dropper. A dropper caliorated such that the volume error incurred in measuring any liquid does not exceed 15 percent under normal use conditions.

§ 341.14 Antitussive active ingredients.

The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in $341.74(d):

(a) Oral antitussives. (1) Chlophedianol hydrochloride.

(2) Codeine ingredients. The following ingredients may be used only in combination in accordance with $$ 329.20(a) and 341.40 and 21 CFR 1308.15(c).

(i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3) Dextromethorphan. (4) Dextromethorphan hydrobromide. (5) Diphenhydramine citrate. (6) Diphenhydramine hydrochloride. (b) Topical antitussives. (1) Camphor. (2) Menthol.

(52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994]

8341.16 Bronchodilator active ingredi

ents.

(51 FR 35339, Oct. 2, 1986, as amended at 54 FR 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, 1994)

Subpart B-Active Ingredients

The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient:

(a) Ephedrine.
(b) Ephedrine hydrochloride.
(c) Ephedrine sulfate.
(d) Epinephrine.
(e) Epinephrine bitartrate.
(f) Racephedrine hydrochloride.
(8) Racepinephrine hydrochloride.

8 341.12 Antihistamine active ingredi

ents. The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient:

(a) Brompheniramine maleate.
(b) Chlorcyclizine hydrochloride.

(51 FR 35339, Oct. 2, 1986)

8341.18 Expectorant active ingredient.

The active ingredient of the product is guaifenesin when used within the dosage limits established in 8341.78(d).

all of the warnings in $341.74(c) shall be used. The directions for OTC labeling shall follow $$ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow $341.90(j) or (k), as applicable.

(b) (Reserved)

[54 FR 8509, Feb. 28, 1989)

[61 FR 15703, Apr. 9, 1996)

8341.20 Nasal decongestant active in

gredients. The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient:

(a) Oral nasal decongestants. (1) Phenylephrine hydrochloride.

(2) Pseudoephedrine hydrochloride. (3) Pseudoephedrine sulfate.

(b) Topical nasal decongestants. (1) [Reserved]

(2) Ephedrine.
(3) Ephedrine hydrochloride.
(4) Ephedrine sulfate.
(5) [Reserved]
(6) Naphazoline hydrochloride.
(7) Oxymetazoline hydrochloride.
(8) Phenylephrine hydrochloride.
(9) Propylhexedrine.
(10) Xylometazoline hydrochloride.

(59 FR 43409, Aug. 23, 1994]

8341.72 Labeling of antihistamine

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 "antihistamine."

(b) Indications. The labeling of the product states, under the heading “Indications,” any of the phrases listed in paragraph (b) of this section, as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph, 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) "Temporarily” (select one of the following: "relieves,' "alleviates," "decreases, "reduces," “dries") "runny nose and" (select one of the following: "relieves," "alleviates, “decreases,"

“reduces”) “sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever" (which may be followed by one or both of the following: “or other upper respiratory allergies" or "(allergic rhinitis)").

(2) “For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever" (which may be followed by one or both of the following: “or other upper respiratory allergies” or "(allergic rhinitis)'').

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

(1) "May cause excitability especially in children."

(2) “Do not take this product, unless directed by a doctor, if you have a

or

or

or

Subpart C-Labeling § 341.70 Labeling of OTC drug prod

ucts containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient

or combination drug product). The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words phrases so that the resulting information is clear and understandable. (a)

For products containing diphenhydramine

citrate

and diphenhydramine hydrochloride identified in § 341.14(a)(5) and (a)(6). The labeling of the product contains the established name of the drug, if any, and identifies the product as an "antihistamine/ cough suppressant" or "antihistamine/ antitussive (cough suppressant).” The indications shall be combined from $$341.72(b) and 341.74(b). The warnings shall be combined from $$341.72(c)(1), (c)(2), (c)(4), and (c)(6) and 341.74(c)(1), (c)(2), (c)(3), and (c)(4). Alternatively,

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