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breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland."

(3) For products containing brompheniramine maleate, chlorcyclizine hydrochloride, chlorpheniramine maleate, dexbrompheniramine

maleate, derchlorpheniramine

maleate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, or triprolidine hydrochloride identified in $ 341.12(a), (b), (c), (d), (e), (i), (i), (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, doxylamine succinate identified in $ 341.12(1), (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 containing brompheniramine

maleate, chlorpheniramine

maleate, dezbrompheniramine

maleate, derchlorpheniramine

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

drochloride, or triprolidine hydrochloride identified in $341.12(a), (c), (d), (e), (i), (i), (k), (1), 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, dozylamine succinate identified in $ 341.12(1), (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.

(5) For products containing dexchlorpheniramine maleate identified in 8341.12(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.

(9) For

products containing phenindamine 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(). 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 doctor. Children under 6 years of age: consult a doctor.

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

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

8341.74 Labeling of antitussive drug

products.

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(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “cough suppressant”

"antitussive (cough suppressant).”

(b) Indications. The labeling of the product states, under the heading “Indications," any of the phrases listed in this paragraph (b), 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), 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,”

“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”).

(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."

(0) (Select one of the following: “Alleviates, “Controls,” “Decreases,” “Reduces,'s “Relieves,"

"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

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product for persistent or chronic cough $ 341.14(a)(3) and (a)(4) when labeled such as occurs with smoking, asthma, only for children under 12 years of age. or emphysema, or if cough is accom- Drug interaction precaution. Do not panied by excessive phlegm (mucus) give this product to a child who is takunless directed by a doctor."

ing a prescription monoamine oxidase (3) For oral and topical antitussives la

inhibitor (MAOI) (certain drugs for debeled only for children under 12 years of pression, psychiatric or emotional conage. “Do not give this product for per

ditions), or for 2 weeks after stopping sistent or chronic cough such as occurs

the MAOI drug. If you are uncertain with asthma or if cough is accom

whether your child's prescription drug panied by excessive phlegm (mucus)

contains an MAOI, consult a health unless directed by a doctor."

professional before giving this prod(4) Oral antitussives—(i) For products

uct.' containing codeine ingredients identified

For

(vii) in § 341.14(a)(2). “May cause or aggra

products containing

citrate

diphenhydramine vate constipation.(ii) For products containing codeine in

diphenhydramine hydrochloride identified gredients identified in $ 341.14(a)(2) when

in $ 341.14(a)(5) and (a)(6). May cause labeled only for adults. Do not take excitability especially in children." this product if you have a chronic pul- (viii) For products containing monary disease or shortness of breath diphenhydramine

citrate

OT unless directed by a doctor."

diphenhydramine hydrochloride identified (iii) For products containing codeine in- in § 341.14(a)(5) and (a)(6) when labeled gredients identified in 8 341.14(a)(2) when only for children under 12 years of agelabeled only for children under 12 years of (A) “Do not give this product to chilage. Do not give this product to chil- dren who have a breathing problem dren who have a chronic pulmonary such as chronic bronchitis, or who have disease, shortness of breath, or who are

glaucoma, without first consulting the taking other drugs unless directed by a

child's doctor." doctor."

(B) “May cause marked drowsiness. (iv) For products containing codeine in

Sedatives and tranquilizers may ingredients identified in $ 341.14(a)(2) when

crease the drowsiness effect. Do not labeled for use in adults and children

give this product to children who are under 12 years of age. “Adults and chil

taking sedatives or tranquilizers, withdren who have a chronic pulmonary disease or shortness of breath, or chil

out first consulting the child's doctor."

For

(ix) dren who are taking other drugs,

products containing should not take this product unless di

diphenhydramine

citrate rected by a doctor."

diphenhydramine hydrochloride identified (v) For products containing

in § 341.14(a)(5) and (a)(6) when labeled dextromethorphan of dextromethorphan for use in adults and children under 12 hydrobromide

identified in years of age-(A) "Do not take this 8341.14(a)(3) and (a)(4) when labeled for product, unless directed by a doctor, if adults or for adults and children under you have a breathing problem such as 12 years of age. Drug interaction pre- emphysema or chronic bronchitis, or if caution. Do not use this product if you you have glaucoma or difficulty in uriare now taking a prescription mono- nation due to enlargement of the prosamine oxidase inhibitor (MAOI) (cer- tate gland.” tain drugs for depression, psychiatric

(B) “May cause marked drowsiness; or emotional conditions, or Parkin

alcohol, sedatives, and tranquilizers son's disease), or for 2 weeks after stop

may increase the drowsiness effect. ping the MAOI drug. If you are uncer

Avoid alcoholic beverages while taking tain whether your prescription drug

this product. Do not take this product contains an MAOI, consult a health professional before taking this prod

if you are taking sedatives or tranquil

izers, without first consulting your uct." (vi)

doctor. Use caution when driving a For products containing dextromethorphan or dextromethorphan

motor vehicle or operating machinhydrobromide as identified in

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as

ery."

(5) Topical antitussives—(1) 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(5) (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(6)(1) in a suitable ointment vehicle. 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

179-070 0-98-9

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