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phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, or triprolidine hydrochloride identified in §341.12(a), (b), (c), (d), (e), (i), (j), (k), (l), and (m). "May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery."

(4) For products containing diphenhydramine citrate, diphenhydramine hydrochloride, ΟΥ doxylamine succinate identified in § 341.12(f), (g), and (h). "May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.”

(5) For products containing phenindamine tartrate identified in $341.12(i). "May cause nervousness and insomnia in some individuals.'

(6) For products that are labeled only for use by children under 12 years of age. The labeling of the product contains only the warnings identified in paragraphs (c)(1) and (c)(5) of this section as well as the following:

(i) "Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor."

(ii) For products brompheniramine

chlorpheniramine

containing

maleate, maleate, maleate, maleate,

dexbrompheniramine dexchlorpheniramine phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hy

drochloride, or triprolidine hydrochloride identified in §341.12(a), (c), (d), (e), (i), (j), (k), (l), and (m). “May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.” (iii) For products containing diphenhydramine citrate, diphenhydramine hydrochloride, or doxylamine succinate identified in $341.12(f), (g), and (h). "May cause marked drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.”

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

(1) For products containing brompheniramine maleate identified in $341.12(a). Adults and children 12 years of age and over: oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 24 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(2) For products containing chlorcyclizine hydrochloride identified in § 341.12(b). Adults and children 12 years of age and over: oral dosage is 25 milligrams every 6 to 8 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 12 years of age: consult a doctor.

(3) For products containing chlorpheniramine maleate identified in $341.12(c). Adults and children 12 years of age and over: oral dosage is 4 milligrams every 4 to 6 hours, not to exceed 24 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(4) For products containing dexbrompheniramine maleate identified in $341.12(d). Adults and children 12 years

of age and over: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

containing

(5) For products dexchlorpheniramine maleate identified in $341.12(e). Adults and children 12 years of age and over: oral dosage is 2 milligrams every 4 to 6 hours, not to exceed 12 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 1 milligram every 4 to 6 hours, not to exceed 6 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(6) For products containing diphenhydramine citrate identified in §341.12(f). Adults and children 12 years of age and over: oral dosage is 38 to 76 milligrams every 4 to 6 hours, not to exceed 456 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 19 to 38 milligrams every 4 to 6 hours, not to exceed 228 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(7) For products containing diphenhydramine hydrochloride identified in $341.12(g). 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. Children under 6 years of age: consult a doctor.

(8) For products containing doxylamine succinate identified in §341.12(h). Adults and children 12 years of age and over: oral dosage is 7.5 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 3.75 to 6.25 milligrams every 4 to 6 hours, not to exceed 37.5 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

For

(9) phenindamine

products containing tartrate identified in § 341.12(i). Adults and children 12 years of age and over: oral dosage is 25 milligrams every 4 to 6 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(10) For products containing pheniramine maleate identified in § 341.12(j). Adults and children 12 years of age and over: 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. Children 6 to under 12 years of age: oral dosage is 6.25 to 12.5 milligrams every 4 to 6 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(11) For products containing pyrilamine maleate identified in §341.12(k). Adults and children 12 years of age and over: oral dosage is 25 to 50 milligrams every 6 to 8 hours, not to exceed 200 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 6 to 8 hours, not to exceed 100 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(12) For products containing thonzylamine hydrochloride identified in $341.12(1). Adults and children 12 years of age and over: oral dosage is 50 to 100 milligrams every 4 to 6 hours, not to exceed 600 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: 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 under 6 years of age: consult a doctor.

(13) For products containing triprolidine hydrochloride identified in $341.12(m). Adults and children 12 years of age and over: oral dosage is 2.5 milligrams every 4 to 6 hours, not to exceed 10 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 1.25 milligrams every 4 to 6 hours, not to exceed 5 milligrams in 24 hours, or as directed by a

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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), 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) "Temporarily" (select one of the following: “alleviates," "calms," "controls," "decreases," "quiets,' "reduces," "relieves," or "suppresses") "cough due to" (select one of the following: "minor bronchial irritation" or "minor throat and bronchial irritation") (select one of the following: "“as may occur with," "associated with,” or "occurring with") (select one of the following: "A cold" or "the common cold") "or inhaled irritants."

(2) "Temporarily” (select one of the following: “alleviates," "calms," "controls," "decreases," "quiets,' "reduces,' "relieves, or "suppresses”) "cough" (select one of the following: "as may occur with, with," "associated with," or "occurring with”) (select one of the following: "A cold," "the common cold," or "inhaled irritants”).

(3) In addition to the required information identified in paragraphs (b) (1) and (2) of this section, the labeling of the product may contain any (one or more) of the following statements:

(i) “Cough suppressant which temporarily" (select one of the following: "Alleviates," "controls," "decreases, "reduces," "relieves," or "suppresses") "the impulse to cough."

(ii) "Temporarily helps you cough less."

(iii) "Temporarily helps to" (select one of the following: "Alleviate," "control," "decrease," "reduce," "relieve," or "suppress") "the cough reflex that causes coughing."

(iv) “Temporarily" (select one of the following: "Alleviates, "controls," "decreases," "reduces," "relieves," or "suppresses") "the intensity of coughing."

(v) (Select one of the following: "Alleviates," "Controls," "Decreases," "Reduces," "Relieves, or "Suppresses") (select one of the following: "Cough," "the impulse to cough," or "your cough") "to help you" (select one of the following: "Get to sleep," "sleep," or "rest").

or

(vi) For products containing chlophedianol hydrochloride, codeine ingredients, dextromethorphan, dextromethorphan hydrobromide identified in $341.14(a) (1), (2), (3), and (4). "Calms the cough control center and relieves coughing."

(vii) For products containing chlophedianol hydrochloride, dextromethorphan, dextromethorphan hydrobromide, camphor, or menthol identified in §341.14(a) (1), (3), (4) and (b) (1) and (2). (a) "Nonnarcotic cough suppressant for the temporary” (select one of the following: "alleviation," "control," "decrease,' "reduction,' "relief," or "suppression") "of cough.”

(b) (Select one of the following: "Alleviates," "Controls," "Decreases," "Reduces,' "Relieves," or "Suppresses") "cough impulses without narcotics."

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

(1) For oral and topical antitussives. “A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor."

(2) For oral and topical antitussives labeled for adults or for adults and children under 12 years of age. "Do not take this

product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor."

(3) For oral and topical antitussives labeled only for children under 12 years of years of age. “Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor."

(4) Oral antitussives—(i) For products containing codeine ingredients identified in $341.14(a)(2). "May cause or aggravate constipation.”

(ii) For products containing codeine ingredients identified in §341.14(a)(2) when labeled only for adults. "Do not take this product if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor."

(iii) For products containing codeine ingredients identified in $341.14(a)(2) when labeled only for children under 12 years of age. "Do not give this product to children who have a chronic pulmonary disease, shortness of breath, or who are taking other drugs unless directed by a doctor."

(iv) For products containing codeine ingredients identified in $341.14(a)(2) when labeled for use in adults and children under 12 years of age. "Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are are taking other drugs, should not take this product unless directed by a doctor."

(v) For products containing dextromethorphan or dextromethorphan hydrobromide as identified in $341.14(a)(3) and (a)(4) when labeled for adults or for adults and children under 12 years of age. “Drug interaction precaution. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product."

(vi) For products containing dextromethorphan or dextromethorphan hydrobromide as identified in

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ΟΤ

diphenhydramine hydrochloride identified in §341.14(a)(5) and (a)(6). “May cause excitability especially in children." (viii) For products containing diphenhydramine citrate diphenhydramine hydrochloride identified in $341.14(a)(5) and (a)(6) when labeled only for children under 12 years of age(A) "Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor."

or

(B) "May cause marked drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor." (ix) For products containing diphenhydramine citrate diphenhydramine hydrochloride identified in $341.14(a)(5) and (a)(6) when labeled for use in adults and children under 12 years of age-(A) "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."

(B) "May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery."

(5) Topical antitussives—(i) For products containing camphor or menthol identified in §341.14(b) (1) and (2) in a suitable ointment vehicle. “For external use only. Do not take by mouth or place in nostrils."

(ii) For products containing camphor or menthol identified in § 341.14(b) (1) and (2) for steam inhalation use. "For steam inhalation only. Do not take by mouth.'

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

(1) Oral antitussives—(i) For products containing chlophedianol hydrochloride identified in §341.14(a)(1). Adults and children 12 years of age and over: Oral dosage is 25 milligrams every 6 to 8 hours, not to exceed 100 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 12.5 milligrams every 6 to 8 hours, not to exceed 50 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.

(ii) For products containing codeine ingredients identified in $341.14(a)(2). Adults and children 12 years of age and over: Oral dosage is 10 to 20 milligrams every 4 to 6 hours, not to exceed 120 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 5 to 10 milligrams every 4 to 6 hours, not to exceed 60 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

(iii) For products containing dextromethorphan or dextromethorphan hydrobromide identified in §341.14(a) (3) and (4). The dosage is equivalent to dextromethorphan hydrobromide.

Adults and children 12 years of age and over: Oral dosage is 10 to 20 milligrams every 4 hours or 30 milligrams every 6 to 8 hours, not to exceed 120 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 5 to 10 milligrams every 4 hours or 15 milligrams every 6 to 8 hours, not to exceed 60 milligrams in 24

hours, or as directed by a doctor. Children 2 to under 6 years of age: Oral dosage is 2.5 to 5 milligrams every 4 hours or 7.5 milligrams every 6 to 8 hours, not to exceed 30 milligrams in 24 hours, or as directed by a doctor. Children under 2 years of age: Consult a doctor. (iv)

For products containing diphenhydramine citrate identified in §341.14(a)(5). Adults and children 12 years of age and over: oral dosage is 38 milligrams every 4 hours, not to exceed 228 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 19 milligrams every 4 hours, not to exceed 114 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(v) For products containing diphenhydramine hydrochloride identified in §341.14(a)(6). Adults and children 12 years of age and over: oral dosage is 25 milligrams every 4 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: oral dosage is 12.5 milligrams every 4 hours, not to exceed 75 milligrams in 24 hours, or as directed by a doctor. Children under 6 years of age: consult a doctor.

(2) Topical antitussives—(i) For products containing camphor identified in §341.14(b)(1) in a suitable ointment ve- · hicle. The product contains 4.7 to 5.3 percent camphor. Adults and children 2 to under 12 years of age: Rub on the throat and chest as a thick layer. The area of application may be covered with a warm, dry cloth if desired. However, clothing should be left loose about the throat and chest to help the vapors rise to reach the nose and mouth. Applications may be repeated up to three times daily or as directed by a doctor. Children under 2 years of age: consult a doctor.

(ii) For products containing menthol identified in §341.14(b)(2) in a suitable ointment vehicle. The product contains 2.6 to 2.8 percent menthol. Adults and children 2 to under 12 years of age: Rub on the throat and chest as a thick layer. The area of application may be covered with a warm, dry cloth if desired. However, clothing should be left loose about the throat and chest to help the vapors rise to reach the nose

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