Food and Drug Administration, HHS § 341.20 (d) Expectorant drug. A drug taken (m) Triprolidine hydrochloride. orally to promote or facilitate the re- [57 FR 58374, Dec. 9, 1992, as amended at 59 moval of secretions from the res- FR 4218, Jan. 28, 1994] piratory airways. (e) Antihistamine drug. A drug used § 341.14 Antitussive active ingredients. for the relief of the symptoms of hay The active ingredients of the product fever and upper respiratory allergies consist of any of the following when (allergic rhinitis). used within the dosage limits and in (f) Oral nasal decongestant drug. A the dosage forms established for each drug that is taken by mouth and acts ingredient in § 341.74(d): systemically to reduce nasal conges- (a) Oral antitussives. (1) Chlophedianol tion caused by acute or chronic rhi- hydrochloride. nitis. (2) Codeine ingredients. The following (g) Topical nasal decongestant drug. A ingredients may be used only in com- drug that when applied topically inside bination in accordance with §§ 290.2 and the nose, in the form of drops, jellies, 21 CFR 1308.15(c). or sprays, or when inhaled intranasally (i) Codeine. reduces nasal congestion caused by (ii) Codeine phosphate. acute or chronic rhinitis. (iii) Codeine sulfate. (h) Calibrated dropper. A dropper cali- (3) Dextromethorphan. brated such that the volume error in- (4) Dextromethorphan hydrobromide. curred in measuring any liquid does (5) Diphenhydramine citrate. not exceed 15 percent under normal use (6) Diphenhydramine hydrochloride. conditions. (b) Topical antitussives. (1) Camphor. (i) Effervescent dosage form. A dosage (2) Menthol. form intended to be dissolved in water [52 FR 30055, Aug. 12, 1987, as amended at 59 before administration. It contains, in FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002] addition to the active ingredient(s), mixtures of acids (citric acid, tartaric § 341.16 Bronchodilator active ingredi- acid) and sodium bicarbonate, which ents. release carbon dioxide when dissolved The active ingredients of the product in water. consist of any of the following when used within the dosage limits estab- [51 FR 35339, Oct. 2, 1986, as amended at 54 FR lished for each ingredient: 8509, Feb. 28, 1989; 55 FR 40382, Oct. 3, 1990; 57 (a) Ephedrine. FR 58374, Dec. 9, 1992; 59 FR 43409, Aug. 23, 1994; 71 FR 43362, Aug. 1, 2006] (b) Ephedrine hydrochloride. (c) Ephedrine sulfate. (d) Epinephrine. Subpart B—Active Ingredients (e) Epinephrine bitartrate. (f) Racephedrine hydrochloride. § 341.12 Antihistamine active ingredi- (g) Racepinephrine hydrochloride. ents. [51 FR 35339, Oct. 2, 1986] The active ingredient of the product consists of any of the following when § 341.18 Expectorant active ingredient. used within the dosage limits estab- lished for each ingredient: The active ingredient of the product is guaifenesin when used within the (a) Brompheniramine maleate. dosage limits established in § 341.78(d). (b) Chlorcyclizine hydrochloride. (c) Chlorpheniramine maleate. [54 FR 8509, Feb. 28, 1989] (d) Dexbrompheniramine maleate. § 341.20 Nasal decongestant active in- (e) Dexchlorpheniramine maleate. gredients. (f) Diphenhydramine citrate. The active ingredient of the product (g) Diphenhydramine hydrochloride. consists of any of the following when (h) Doxylamine succinate. used within the dosage limits and in (i) Phenindamine tartrate. the dosage forms established for each (j) Pheniramine maleate. ingredient: (k) Pyrilamine maleate. (a) Oral nasal decongestants. (1) Phen- (l) Thonzylamine hydrochloride. ylephrine hydrochloride. 243 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00253 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR.