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Nasal Decongestant Active Ingredients

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Nasal Decongestant Active Ingredients 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 § 341.40 21 CFR Ch. I (4–1–11 Edition) (2) Pseudoephedrine hydrochloride. antitussive active ingredient identified (3) Pseudoephedrine sulfate. in § 341.14(a)(1) through (a)(4) provided (4) Phenylephrine bitartrate in an ef- that the product is labeled according to fervescent dosage form. § 341.85(c)(4). Diphenhydramine citrate (b) Topical nasal decongestants. (1) in §§ 341.12(f) and 341.14(a)(5) or Levmetamfetamine. diphenhydramine hydrochloride in (2) Ephedrine. §§ 341.12(g) and 341.14(a)(6) may be both (3) Ephedrine hydrochloride. the antihistamine and the antitussive (4) Ephedrine sulfate. active ingredient provided that the (5) [Reserved] product is labeled according to (6) Naphazoline hydrochloride. § 341.70(a). (7) Oxymetazoline hydrochloride. (e) Any single antihistamine active (8) Phenylephrine hydrochloride. (9) Propylhexedrine. ingredient identified in § 341.12(a) (10) Xylometazoline hydrochloride. through (e) and (h) through (m) may be combined with any single oral [59 FR 43409, Aug. 23, 1994, as amended at 63 antitussive active ingredient identified FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, in § 341.14(a)(1) through (a)(4) and any 2006] single oral nasal decongestant active § 341.40 Permitted combinations of ac- ingredient identified in § 341.20(a) pro- tive ingredients. vided that the product is labeled ac- The following combinations are per- cording to § 341.85(c)(4). mitted provided each active ingredient Diphenhydramine citrate in §§ 341.12(f) is present within the dosage limits es- and 341.14(a)(5) or diphenhydramine hy- tablished in parts 341, 343, and 356 of drochloride in §§ 341.12(g) and this chapter and the product is labeled 341.14(a)(6) may be both the antihis- in accordance with §§ 341.70 or 341.85: tamine and the antitussive active in- (a) Any single antihistamine active gredient provided that the product is ingredient identified in § 341.12 may be labeled according to § 341.70(a). combined with any generally recog- (f) Any single antihistamine active nized as safe and effective single an- ingredient identified in § 341.12(a) algesic-antipyretic active ingredient, through (e) and (h) through (m) may be or any combination of acetaminophen combined with any single oral with other analgesic-antipyretic active antitussive active ingredient identified ingredients, or any aspirin and antacid in § 341.14(a)(1) through (a)(4) and any combination provided that the product generally recognized as safe and effec- is labeled according to § 341.85. tive single analgesic-antipyretic active (b) Any single antihistamine active ingredient, or any combination of acet- ingredient identified in § 341.12 may be aminophen with other analgesic-anti- combined with any single oral nasal de- pyretic active ingredients, or any aspi- congestant active ingredient identified rin and antacid combination provided in § 341.20(a) provided that the product that the product is labeled according to is labeled according to § 341.85. § 341.85(c)(4). Diphenhydramine citrate (c) Any single antihistamine active in §§ 341.12(f) and 341.14(a)(5) or ingredient identified in § 341.12 may be diphenhydramine hydrochloride in combined with any single oral nasal de- congestant active ingredient identified §§ 341.12(g) and 341.14(a)(6) may be both in § 341.20(a) and any generally recog- the antihistamine and the antitussive nized as safe and effective single an- active ingredient provided that the algesic-antipyretic active ingredient, product is labeled according to or any combination of acetaminophen § 341.70(a). with other analgesic-antipyretic active (g) Any single antihistamine active ingredients, or any aspirin and antacid ingredient identified in § 341.12(a) combination provided that the product through (e) and (h) through (m) may be is labeled according to § 341.85. combined with any single oral (d) Any single antihistamine active antitussive active ingredient identified ingredient identified in § 341.12(a) in § 341.14(a)(1) through (a)(4) and any through (e) and (h) through (m) may be single oral nasal decongestant active combined with any single oral ingredient identified in § 341.20(a) and 244 VerDate Mar<15>2010 13:22 May 12, 2011 Jkt 223069 PO 00000 Frm 00254 Fmt 8010 Sfmt 8010 Y:\SGML\223069.XXX 223069 WReier-Aviles on DSKGBLS3C1PROD with CFR.
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