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NDC 59779-0787-15 CVS Health Sinus Relief 0.0005 g/mL Details

CVS Health Sinus Relief 0.0005 g/mL

CVS Health Sinus Relief is a NASAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy,Inc.. The primary component is OXYMETAZOLINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.

Related Packages: 59779-0787-15
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray

Product Information

NDC	59779-0787
Product ID	59779-787_3e15a1f9-c93e-4cdb-865c-68bfa63d3323
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CVS Health Sinus Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	oxymetazoline hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	NASAL
Active Ingredient Strength	0.0005
Active Ingredient Units	g/mL
Substance Name	OXYMETAZOLINE HYDROCHLORIDE
Labeler Name	CVS Pharmacy,Inc.
Pharmaceutical Class	Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59779-0787-15 (59779078715)

Pricing Information	N/A
NDC Package Code	59779-787-15
Billing NDC	59779078715
Package	1 BOTTLE, SPRAY in 1 CARTON (59779-787-15) / 15 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2015-04-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3e15a1f9-c93e-4cdb-865c-68bfa63d3323 Details

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

•: for the temporary relief of sinus/ nasal congestion due to:
•: colds
•: hay fever
•: upper respiratory allergies

Warnings

Ask a doctor before use if you have

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

When using this product

•: do not exceed recommended dosage
•: use of this container by more than one person may spread infection.
•: temporary burning, stinging, sneezing or increase in nasal discharge may occur
•: frequent or prolonged use may cause nasal congestion to recur or worsen

Stop use and ask a doctor

If Symptoms persist for more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away. ( 1-800-222-1222)

Directions

•: adults and children 6 yrs, & older (with adult supervision): 2 or 3 sprays in each nostril without tilting your head, not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24 hours.
•: children 2 to under 6 yrs : ask a doctor
•: children under 2 yrs: Do not use

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

Principal Display Panel

CVS Health ™

Compare to the active ingredient in Vicks® Sinex® *

Nasal Spray

Sinus Relief

OXYMETAZOLINE HCl 0.05%

Nasal decongestant

12 HOUR

NASAL SPRAY FOR SINUS RELIEF

12 Hour

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 Procter & Gamble, the distributor of Vicks®Sinex®

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

CVS.com®

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

CVS Health Sinus Relief Oxymetazoline HCl 0.05% 15 mL

INGREDIENTS AND APPEARANCE

CVS HEALTH SINUS RELIEF

oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-787
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.00050 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTOL (UNII: RV6J6604TK)
MENTHOL (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59779-787-15	1 in 1 CARTON	04/21/2015
1		15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/21/2015

Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 11/2016

Document Id: 3e15a1f9-c93e-4cdb-865c-68bfa63d3323

Set id: 3e15a1f9-c93e-4cdb-865c-68bfa63d3323

Version: 1

Effective Time: 20161102