21 CFR § 341.90 - Professional labeling.

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§ 341.90 Professional labeling.

The labeling of the product provided to health professionals (but not to the general public) may contain the following additional dosage information for products containing the active ingredients identified below:

(a) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, or racephedrine hydrochloride identified in § 341.16 (a), (b), (c), and (f). Children 6 to under 12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 hours, not to exceed 75 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 0.3 to 0.5 milligram per kilogram of body weight every 4 hours, not to exceed 2 milligrams per kilogram of body weight in 24 hours.

(b) For products containing chlophedianol hydrochloride identified in 341.14(a)(1). Children 2 to under 6 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.

(c) For products containing codeine ingredients identified in § 341.14(a)(2).

(1) Children 2 to under 6 years of age: Oral dosage is 1 milligram per kilogram body weight per day administered in four equal divided doses. The average body weight for each age may also be used to determine dosage as follows: For children 2 years of age (average body weight, 12 kilograms), the oral dosage is 3 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours; for children 3 years of age (average body weight, 14 kilograms), the oral dosage is 3.5 milligrams every 4 to 6 hours, not to exceed 14 milligrams in 24 hours; for children 4 years of age (average body weight, 16 kilograms), the oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 16 milligrams in 24 hours: for children 5 years of age (average body weight, 18 kilograms), the oral dosage is 4.5 milligrams every 4 to 6 hours, not to exceed 18 milligrams in 24 hours. The manufacturer must relate these dosages for its specific product dosages for its specific product to the use of the calibrated measuring device discussed in paragraph (c)(3) of this section. If age is used to determine the dose, the directions must include instructions to reduce the dose for low-weight children.

(2) Parents should be instructed to obtain and use a calibrated measuring device for administering the drug to the child, to use extreme care in measuring the dosage, and not exceed the recommended daily dosage.

(3) A dispensing device (such as a dropper calibrated for age or weight) should be dispensed along with the product when it is intended for use in children 2 to under 6 years of age to prevent possible overdose due to improper measuring of the dose.

(4) Codeine is not recommended for use in children under 2 years of age. Children under 2 years may be more susceptible to the respiratory depressant effects of codeine, including respiratory arrest, coma, and death.

(d) The following labeling indication may be used for products containing guaifenesin identified in § 341.18 when used as a single ingredient product. “Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.”

(e) For products containing brompheniramine maleate identified in § 341.12(a). Children 2 to under 6 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.

(f) For products containing chlorcyclizine hydrochloride identified in § 341.12(b). Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 37.5 milligrams in 24 hours. Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 6 to 8 hours, not to exceed 18.75 milligrams in 24 hours.

(g) For products containing chlorpheniramine maleate identified in § 341.12(c). Children 2 to under 6 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours.

(h) For products containing dexbrompheniramine maleate identified in § 341.12(d). Children 2 to under 6 years of age: oral dosage is 0.5 milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.

(i) For products containing dexchlorpheniramine maleate identified in § 341.12(e). Children 2 to under 6 years: oral dosage is 0.5 milligram every 4 to 6 hours, not to exceed 3 milligrams in 24 hours.

(j) For products containing diphenhydramine citrate identified in § 341.12(f). Children 2 to under 6 years of age: oral dosage is 9.5 milligrams every 4 to 6 hours, not to exceed 57 milligrams in 24 hours.

(k) For products containing diphenhydramine hydrochloride identified in § 341.12(g). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 mg in 24 hours.

(l) For products containing doxylamine succinate identified in § 341.12(h). Children 2 to under 6 years of age: oral dosage is 1.9 to 3.125 milligrams every 4 to 6 hours, not to exceed 18.75 milligrams in 24 hours.

(m) For products containing phenindamine tartrate identified in § 341.12(i). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours.

(n) For products containing pheniramine maleate identified in § 341.12(j). Children 2 to under 6 years of age: oral dosage is 3.125 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours.

(o) For products containing pyrilamine maleate identified in § 341.12(k). Children 2 to under 6 years of age: oral dosage is 6.25 to 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours.

(p) For products containing thonzylamine hydrochloride identified in § 341.12(l). Children 2 to under 6 years of age: oral dosage is 12.5 to 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours.

(q) For products containing triprolidine hydrochloride identified in § 341.12(m). Children 4 to under 6 years of age: oral dosage is 0.938 milligram every 4 to 6 hours, not to exceed 3.744 milligrams in 24 hours. Children 2 to under 4 years of age: oral dosage is 0.625 milligram every 4 to 6 hours, not to exceed 2.5 milligrams in 24 hours. Infants 4 months to under 2 years of age: oral dosage is 0.313 milligram every 4 to 6 hours, not to exceed 1.252 milligrams in 24 hours.

(r) For products containing diphenhydramine citrate identified in § 341.14(a)(5). Children 2 to under 6 years of age: oral dosage is 9.5 milligrams every 4 hours, not to exceed 57 milligrams in 24 hours.

(s) For products containing diphenhydramine hydrochloride identified in § 341.14(a)(6). Children 2 to under 6 years of age: oral dosage is 6.25 milligrams every 4 hours, not to exceed 37.5 milligrams in 24 hours.

[51 FR 35339, Oct. 2, 1986, as amended at 52 FR 30057, Aug. 12, 1987; 54 FR 8509, Feb. 28, 1989; 57 FR 58376, Dec. 9, 1992; 59 FR 4218, Jan. 28, 1994; 59 FR 29174, June 3, 1994; 59 FR 36051, July 15, 1994]

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