Nasal Spray
FDA Label NDC 42507-796

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Nasal (NDC 42507-796). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure

Ask A Doctor Before Use If You Have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland

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.
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection

Stop Use And Ask A Doctor If

  • symptoms persist

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Shake well before use. Hold white tabs, SQUEEZE grooved area of cap FIRMLY and turn counter clockwise. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply. Secure cap after use.

adults & children

6 yrs. & older

(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 24 hours.

children 2 to under 6 yrs.

ask a doctor

children under 2 yrs.

do not use

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

benzalkonium chloride solution, benzyl alcohol, camphor, dibasic sodium phosphate, edetate disodium, eucalyptol, menthol, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions Or Comments?

1-800-289-8343

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Hy•Vee®

Compare To Sinex® Severe Active Ingredient

Maximum Strength

Nasal Spray

Oxymetazoline HCl 0.05%

Nasal Decongestant

Severe

Original With Menthol

• Sinus Congestion & Pressure

• Fast & Powerful Relief

• Ultra Fine Mist

12 HOUR RELIEF

1 FL OZ (30 mL)

Nasal-spray (Nasal Spray)

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