Cvs Health Spray
FDA Label NDC 69842-575

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 69842-575). 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

  • For the temporary relief of nasal congestion due to

    the common cold, hay fever or other 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
  • thyroid disease
  • diabetes
  • 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 and prolonged use may cause nasal congestion to recur and to 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 within any 24-hour period.
  • children under 6 years of age: ask a doctor. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other Information

  • store between 20°-25°C (68°-77°F)

Inactive Ingredients

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

Principal Display Panel

CVS Health ™

Compare to the active ingredient in Afrin® Original*

NDC 69842-575-15

Original

Nasal Spray

OXYMETAZOLINE HCl

Nasal decongestant

12 HOUR NASAL SPRAY

Fast, Powerful Congestion Relief

1/2 FL OZ (15 mL)

DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSNG

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

*This product is not manufactured or distributed by Bayer Inc., the distributor of Afrin® Original

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI 02895

© 2015 CVS/pharmacy

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Cvs Health Nasal Spray (Image 01)

Cvs Health Nasal Spray (Image 01)

* Please review the disclaimer below.