Cvs Health Spray
FDA Label NDC 69842-715

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Health (NDC 69842-715). 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 hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

  • ▪temporarily relief of nasal congestion due to the
  • ▪common cold
  • ▪hay fever
  • ▪upper respiratory allergies
  • ▪temporarily relieves sinus congestion and pressure
  • ▪shrinks swollen nasal membranes so you can breathe more freely

Ask A Doctor Before Use If You Have

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

When Using This Product

  • ▪do not use more than directed
  • ▪do not use 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 at (1-800-222-1222).

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: ask a doctor

    • Shake well before use. Before using the first time, remove the protective cap from the tip by pressing and twisting off the cap. Rotate the lock tab to align arrow marks to unlock the pump. Prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers without titling head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Lock the pump by ensuring that arrow marks are not aligned and replace the protective cap on tip.

Other Information

  • ▪store at room temperature

Inactive Ingredients

benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

CVS Health™

NDC# 69842-715-15

Compare to the active ingredient in AFRIN® Original Pump Mist*

Sinus

Nasal Spray

OXYMETAZOLINE HCl 0.05%

Nasal Decongestant

Fast, Powerful Congestion Relief

For Colds & Allergies

12 HOUR NASAL SPRAY

  • Fast, powerful congestion relief
  • Relieves painful sinus pressure
  • Cold & allergies

    • 0.5 FL OZ (15 mL)

    IMPORTANT: KEEP THE CARTON FOR FUTURE REFERENCE ON FULL LABELING

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2019 CVS/pharmacy

    CVS.com

    1-800-SHOP CVS, V-12431

    • ✓CVS Quality

      Money Back Guarantee

      • *This product is not manufactured or distributed by Bayer Healthcare LLC, distributer of Afrin® Original Pump Mist.

* Please review the disclaimer below.