FDA.reportPublic FDA data

CVS Health ™ Nasal Spray Drug Facts

Manufacturer
CVS PHARMACY, INC
Effective date
2019-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:23:55

Label at a glance#

ProductCVS Health
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for the temporary relief of nasal congestion due to: ▪ common cold ▪ hay fever ▪ upper respiratory allergies

Dosage and administration

▪ adults and children 12 years of age & older: 2 or 3 sprays in each nostril not more often than every 4 hours ▪ children under 12 years of age: ask a doctor ▪ Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Storage and handling

▪ store at room Temperature ▪ Container is filled to proper level for best spray action

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of nasal congestion due to:

  • common cold
  • hay fever
  • upper respiratory allergies

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • do not use for more than 3 days. Use only as directed.
  • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
  • the use of this container by more than one person may spread infection
  • frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age & older: 2 or 3 sprays in each nostril not more often than every 4 hours
  • children under 12 years of age: ask a doctor
  • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other information

STORAGE AND HANDLING SECTION

  • store at room Temperature
  • Container is filled to proper level for best spray action

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in 4-Way® Nasal Spray

Fast-Acting

NDC 69842-827-30

CVS Health™

Nasal Spray

Phenylephrine Hydrochloride 1 %

Nasal Decongestant

Relief of:

  • Nasal congestion
  • Sinus congestion
  • Sinus pressure
  • Swollen nasal membranes

1 FL OZ (30mL)

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

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

CVS Quality Money Back Guarantee

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

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., the owner of the registered trademark 4-Way® Nasal Spray.

CVS Health Nasal Spray
CVS Health Nasal Spray

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-82769842-827-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BENZYL ALCOHOLLKG8494WBHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fc6d44ea-4680-4304-a317-fcb8f2bb3c60ec8e8dd3-d353-47f5-a448-cb6e5715b8c82019-08-01WarningsExact identifier
spl set id: ec8e8dd3-d353-47f5-a448-cb6e5715b8c8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.