---
kind: "section"
citation: "21 C.F.R. § 341.80"
title: "21"
number: "341.80"
heading: "Labeling of nasal decongestant drug products."
url: "https://uscodex.org/cfr/21/341.80"
---

# §341.80. Labeling of nasal decongestant drug products.

- (a) **Statement of identity.** The labeling of the product contains the established name of the drug, if any, and identifies the product as a “nasal decongestant.”
- (b) **Indications.** The labeling of the product states, under the heading “Indications,” the phrase listed in [paragraph (b)(1)](#b-1) of this section, as appropriate, and may contain any additional phrases listed in [paragraph (b)(2)](#b-2) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraphs [(b)(1)](#b-1) and [(b)(2)](#b-2) of this section, may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=a) of the act.
  - (1) (Select one of the following: “For the temporary relief of nasal congestion” or “Temporarily relieves nasal congestion”) (which may be followed by any of the following in [paragraphs (b)(1)](#b-1) (i), (ii), and (iii) of this section):
    - (i) “due to” (select one of the following: “the common cold” or “a cold”).
    - (ii) “due to” (select one of the following: “hay fever,” “hay fever (allergic rhinitis),” “hay fever or other upper respiratory allergies,” or “hay fever or other upper respiratory allergies (allergic rhinitis)”).
  - (2) In addition to the information identified in [paragraph (b)(1)](#b-1) of this section, the labeling of the product may contain any (one or more) of the following statements:
    - (i) (Select one of the following: “For the temporary relief of” or “Temporarily relieves”) (select one of the following: “stuffy nose,” “stopped up nose,” “nasal stuffiness,” or “clogged up nose.”)
    - (ii) (Select one of the following: “Reduces swelling of,” “Decongests,” or “Helps clear”) “nasal passages; shrinks swollen membranes.”
    - (iii) “Temporarily restores freer breathing through the nose.”
    - (iv) “Helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure.”
    - (v) “Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.”
- (c) **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)](#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)](#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-i), [(c)(2)(ii)](#c-2-ii), [(c)(2)(iii)](#c-2-iii), and [(c)(2)(v)](#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:
  - (2) **Topical nasal decongestants—**
    - (i) **For products containing levmetamfetamine identified in § 341.20(b)(1) when used in an inhalant dosage form.** The product delivers in each 800 milliliters of air 0.04 to 0.150 milligrams of levmetamfetamine. Adults: 2 inhalations in each nostril not more often than every 2 hours. Children 6 to under 12 years of age (with adult supervision): 1 inhalation in each nostril not more often than every 2 hours. Children under 6 years of age: ask a doctor.
    - (ii) **For products containing ephedrine, ephedrine hydrochloride, or ephedrine sulfate identified in § 341.20(b) (2), (3), and (4)—**
      - (A) **Nasal drops or sprays—For a 0.5-percent aqueous solution.** Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Children 6 to under 12 years of age (with adult supervision): 1 or 2 drops or sprays in each nostril not more often than every 4 hours. Children under 6 years of age: consult a doctor.
      - (B) **Nasal jelly—** For a 0.5-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours.
    - (iii) **For products containing naphazoline hydrochloride identified in § 341.20(b)(6)—**
      - (A) **Nasal drops or sprays—** (1) For a 0.05-percent aqueous solution. Adults and children 12 years of age and over: 1 or 2 drops or sprays in each nostril not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (2) For a 0.025-percent aqueous solution. Children 6 to under 12 years of age (with adult supervision): 1 or 2 drops or sprays in each nostril not more often than every 6 hours. Children under 6 years of age: consult a doctor.

      - (B) **Nasal jelly—** (1) For a 0.05-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 6 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (2) For a 0.025-percent water-based jelly. Children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 6 hours. Children under 6 years of age: consult a doctor.

    - (iv) **For products containing oxymetazoline hydrochloride identified in § 341.20(b)(7)—**
      - (A) **Nasal drops or sprays—** (1) For a 0.05-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.

        (2) A 0.025-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.027 milligrams of oxymetazoline per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.

      - (B) **Nasal jelly—For a 0.05-percent water-based jelly.** Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age: consult a doctor.
    - (v) **For products containing phenylephrine hydrochloride identified in § 341.20(b)(8)—**
      - (A) **Nasal drops or sprays—** (1) For a 1-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (2) For a 0.5-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (3) For a 0.25-percent aqueous solution. Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Children under 6 years of age: consult a doctor.

        (4) A 0.125-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.135 milligrams of phenylephrine per three drops or three sprays. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 4 hours. Use only recommended amount. [previous sentence in boldface type] Children under 2 years of age: consult a doctor.

      - (B) **Nasal jelly—** (1) For a 1-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (2) For a 0.5-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (3) For a 0.25-percent water-based jelly. Adults and children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 4 hours. Children under 6 years of age: consult a doctor.

    - (vi) **For products containing propylhexedrine identified in § 341.20(b)(9) when used in an inhalant dosage form.** The product delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of propylhexedrine. Adults and children 6 to under 12 years of age (with adult supervision): 2 inhalations in each nostril not more often than every 2 hours. Children under 6 years of age: consult a doctor.
    - (vii) **For products containing xylometazoline hydrochloride identified in § 341.20(b)(10)—**
      - (A) **Nasal drops or sprays—** (1) For a 0.1-percent aqueous solution. Adults and children 12 years of age and over: 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (2) A 0.05-percent aqueous solution in a container having either a calibrated dropper or a metered-dose spray that delivers no more than 0.054 milligrams of xylometazoline per three drops or three sprays. Children 6 to under 12 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Children 2 to under 6 years of age (with adult supervision): 2 or 3 drops or sprays in each nostril not more often than every 8 to 10 hours. Use only recommended amount. Do not exceed 3 doses in any 24-hour period. [previous two sentences in boldface type] Children under 2 years of age: consult a doctor.

      - (B) **Nasal jelly—** (1) For a 0.1-percent water-based jelly. Adults and children 12 years of age and over: place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 8 to 10 hours. Do not give to children under 12 years of age unless directed by a doctor.

        (2) For a 0.05-percent water-based jelly. Children 6 to under 12 years of age (with adult supervision): place a small amount in each nostril and inhale well back into the nasal passages. Use not more often than every 8 to 10 hours. Children under 6 years of age: consult a doctor.

    - (viii) **Other required statements—For products containing levmetamfetamine or propylhexedrine identified in § 341.20(b)(1) or (b)(9) when used in an inhalant dosage form.**
      - (A) “This inhaler is effective for a minimum of 3 months after first use.”
      - (B) “Keep inhaler tightly closed.”

## Notes

### Amendments

[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 64 FR 13295, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000; 70 FR 58977, Oct. 11, 2005; 71 FR 43362, Aug. 1, 2006]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Amendments

[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 64 FR 13295, Mar. 17, 1999; 65 FR 8, Jan. 3, 2000; 70 FR 58977, Oct. 11, 2005; 71 FR 43362, Aug. 1, 2006]