Nasal Spray Severe Nasal Congestion Relief

Nasal Spray Severe Nasal Congestion Relief
SPL v5
SPL
SPL Set ID 5a7e42ee-810c-4bc1-9d8d-fac8e849e126
Route
NASAL
Published
Effective Date 2022-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Benzyl Alcohol Camphor (natural) Edetate Disodium Eucalyptol Menthol, Unspecified Form Polysorbate 80 Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-10

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9

Stop use and ask a doctor ifsymptoms persist

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Directions
  • adults and children 6 to under 12 years of age (with adult supervision):2 or 3 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.

Shake well before use.

To open:Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using for the first time, prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

DO NOT DISCARD CAP.

Questions?

1-866-467-2748

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at room temperature
Inactive Ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

When Using This Product
  • do not exceed recommended dosage
  • 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
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Principal Display Panel 22 Ml Bottle Carton

*Compare to the active ingredient in Mucinex® SINUS-MAX® CLEAR & COOL Nasal Spray

NDC 69842-614-22



NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

SEVERE NASAL CONGESTION RELIEF

CLEAR & COOL

  • Fast acting
  • Lasts 12 Hours
  • Cooling Menthol

    flavor

3/4 FL OZ (22 mL)

IMPORTANT: Keep this carton for future reference for full labeling.

Distributed By:


Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
    • a cold
    • hay fever or other upper respiratory allergies
  • promotes nasal and sinus drainage
  • temporarily relieves sinus congestion and pressure
  • helps clear nasal passages; shrinks swollen membranes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifsymptoms persist

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Nasal decongestant

Directions
  • adults and children 6 to under 12 years of age (with adult supervision):2 or 3 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.

Shake well before use.

To open:Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using for the first time, prime metered pump by depressing firmly several times. To spray, hold bottle with thumb at the base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress pump all the way down with a firm even stroke and sniff deeply. Wipe nozzle clean after use.

DO NOT DISCARD CAP.

Questions?

1-866-467-2748

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • 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
  • this product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge
  • the use of this container by more than one person may spread infection
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
Principal Display Panel 22 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 22 mL Bottle Carton)

*Compare to the active ingredient in Mucinex® SINUS-MAX® CLEAR & COOL Nasal Spray

NDC 69842-614-22



NASAL SPRAY

Oxymetazoline HCl 0.05%

Nasal Decongestant

SEVERE NASAL CONGESTION RELIEF

CLEAR & COOL

  • Fast acting
  • Lasts 12 Hours
  • Cooling Menthol

    flavor

3/4 FL OZ (22 mL)

IMPORTANT: Keep this carton for future reference for full labeling.

Distributed By:


Advanced Ingredient Data


Raw Label Data

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