Warnings.
Warnings. The labeling of the product contains the following warnings under the heading Warnings:
(1) Oral nasal decongestants -
(i) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for adults.
(A) “Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.”
(B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.”
(C) “Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”
(D) Drug interaction precaution. “Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.”
(ii) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for children under 12 years of age.
(A) “Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.”
(B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.”
(C) “Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”
(D) Drug interaction precaution. “Do not use in a child who is 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 do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.”
(iii) For oral nasal decongestant products labeled for both adults and children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(1)(i) of this section.
(2) Topical nasal decongestants -
(i) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for adults.
(A) “Do not exceed recommended dosage.” [sentence in boldface type]
(B) “This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.”
(C) “The use of this container by more than one person may spread infection.”
(ii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 7 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, ask a doctor.”
(iii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20 (b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for adults.
(A) “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(B) “Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”
(iv) For products containing naphazoline hydrochloride identified in § 341.20(b)(6) at a concentration of 0.05 percent. “Do not use this product in children under 12 years of age because it may cause sedation if swallowed.”
(v) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(vi) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(2)(i) of this section.
(vii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for children under 12 years of age. “Do not use this product for more than 7 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, ask a doctor.”
(viii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20(b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for children under 12 years of age.
(A) “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(B) “Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”
(ix) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for children under 12 years of age. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(x) For topical nasal decongestant products labeled for both adults and for children under 12 years of age. The labeling of the product contains the applicable warnings identified in paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), and (c)(2)(v) of this section.
(d) Directions. The labeling of the product contains the following information under the heading “Directions”:
(1) Oral nasal decongestants -
(i) For products containing phenylephrine hydrochloride identified in § 341.20(a)(1). Adults and children 12 years of age and over: 10 milligrams every 4 hours not to exceed 60 milligrams in 24 hours. Children 6 to under 12 years of age: 5 milligrams every 4 hours not to exceed 30 milligrams in 24 hours. Children 2 to under 6 years of age: 2.5 milligrams every 4 hours not to exceed 15 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(ii) For products containing pseudoephedrine hydrochloride or pseudoephedrine sulfate identified in § 341.20 (a)(2) and (a)(3). Adults and children 12 years of age and over: 60 milligrams every 4 to 6 hours not to exceed 240 milligrams in 24 hours. Children 6 to under 12 years of age: 30 milligrams every 4 to 6 hours not to exceed 120 milligrams in 24 hours. Children 2 to under 6 years of age: 15 milligrams every 4 to 6 hours not to exceed 60 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(iii) For products containing phenylephrine bitartrate identified in § 341.20(a)(4). Include information on the number of dosage units and the quantity of water the dosage units are to be dissolved in prior to administration as shown in the following table:
(1) Oral nasal decongestants -
(i) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for adults.
(A) “Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.”
(B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.”
(C) “Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”
(D) Drug interaction precaution. “Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.”
(ii) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in § 341.20 (a)(1) through (a)(4) when labeled for children under 12 years of age.
(A) “Do not exceed recommended dosage. [first sentence in boldface type] If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.”
(B) “If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.”
(C) “Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”
(D) Drug interaction precaution. “Do not use in a child who is 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 do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.”
(iii) For oral nasal decongestant products labeled for both adults and children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(1)(i) of this section.
(2) Topical nasal decongestants -
(i) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for adults.
(A) “Do not exceed recommended dosage.” [sentence in boldface type]
(B) “This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.”
(C) “The use of this container by more than one person may spread infection.”
(ii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 7 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, ask a doctor.”
(iii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20 (b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for adults.
(A) “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(B) “Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”
(iv) For products containing naphazoline hydrochloride identified in § 341.20(b)(6) at a concentration of 0.05 percent. “Do not use this product in children under 12 years of age because it may cause sedation if swallowed.”
(v) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for adults. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(vi) For products containing any topical nasal decongestant identified in § 341.20(b) when labeled for children under 12 years of age. The labeling of the product contains the warnings identified in paragraph (c)(2)(i) of this section.
(vii) For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form and when labeled for children under 12 years of age. “Do not use this product for more than 7 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, ask a doctor.”
(viii) For products containing ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline hydrochloride, phenylephrine hydrochloride, or xylometazoline hydrochloride identified in § 341.20(b)(2), (b)(3), (b)(4), (b)(6), (b)(7), (b)(8), and (b)(10) when used as nasal sprays, drops, or jellies and when labeled for children under 12 years of age.
(A) “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(B) “Do not use this product in a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.”
(ix) For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form and when labeled for children under 12 years of age. “Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.”
(x) For topical nasal decongestant products labeled for both adults and for children under 12 years of age. The labeling of the product contains the applicable warnings identified in paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), and (c)(2)(v) of this section.
(d) Directions. The labeling of the product contains the following information under the heading “Directions”:
(1) Oral nasal decongestants -
(i) For products containing phenylephrine hydrochloride identified in § 341.20(a)(1). Adults and children 12 years of age and over: 10 milligrams every 4 hours not to exceed 60 milligrams in 24 hours. Children 6 to under 12 years of age: 5 milligrams every 4 hours not to exceed 30 milligrams in 24 hours. Children 2 to under 6 years of age: 2.5 milligrams every 4 hours not to exceed 15 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(ii) For products containing pseudoephedrine hydrochloride or pseudoephedrine sulfate identified in § 341.20 (a)(2) and (a)(3). Adults and children 12 years of age and over: 60 milligrams every 4 to 6 hours not to exceed 240 milligrams in 24 hours. Children 6 to under 12 years of age: 30 milligrams every 4 to 6 hours not to exceed 120 milligrams in 24 hours. Children 2 to under 6 years of age: 15 milligrams every 4 to 6 hours not to exceed 60 milligrams in 24 hours. Children under 2 years of age: consult a doctor.
(iii) For products containing phenylephrine bitartrate identified in § 341.20(a)(4). Include information on the number of dosage units and the quantity of water the dosage units are to be dissolved in prior to administration as shown in the following table: