CVS HEALTH EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT- phenylephrine hydrochloride spray
CVS Pharmacy,Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Health Extra Strength Sinus Relief Phenylephrine HCl 1.0% 1 FL OZ

Active ingredient

Phenylephrine Hydrochloride 1.0 %

Purpose

Nasal decongestant

Uses

•: temporarily relieves nasal congestion:
•: due to common cold
•: due to hay fever or other upper respiratory allergies (allergic rhinitis)
•: temporarily relieves stuffy nose.
•: helps clear nasal passages; shrinks swollen membranes
•: temporarily restores freer breathing through the nose
•: helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Warnings

Ask a doctor before use if you have

•: heart disease
•: high blood pressure
•: thyroid disease
•: diabetes
•: difficulty in urination due to enlargement of the prostate gland

When using this product

• do not exceed recommended dosage

• 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 may occur such as burning, stinging, sneezing and increase in nasal discharge

• use of this container by more than one person may spread infection

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.

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

Directions

•: Use only as directed
•: To spray, squeeze bottle quickly and firmly.

adults and children 12 years older	2 or 3 sprays in each nostril not more often than every 4 hours.
children under 12 years	ask a doctor

Other information

•: store at room temperature
•: protect from light .
•: Keep this carton for future reference on full labeling.

Inactive ingredients

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

Principal Display

CVS Health ™

Compare to the active ingredient in Neo-Synephrine® Extra Strength*

EXTRA STRENGTH

Sinus Relief

PHENYLEPHRINE HCl 1.0 %

Nasal decongestant

FAST RELIEF

Relief of sinus

congestion & pressure

: Easy to use & dispense

1 FL OZ (30mL)

IMPORTANT:

Keep this carton for future reference on full labeling.

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

*CVS /pharmacy® Sinus Relief is not manufactured or distributed by Bayer Healthcare LLC, distributor of Neo-Synephrine® Extra Strength.

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Distributed by: CVS Pharmacy, Inc.

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CVS Health Extra Strength Sinus Relief Phenylephrine HCl 1.0% 1 FL OZ

CVS HEALTH EXTRA STRENGTH SINUS RELIEF NASAL DECONGESTANT
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-771
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-771-30	1 in 1 CARTON	08/18/2015	07/23/2019
1		30 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	08/18/2015	07/23/2019

Labeler - CVS Pharmacy,Inc. (062312574)

Revised: 8/2019

Document Id: 7ace0036-4f32-4811-aaf7-c25951ad044a

Set id: 1f88d11d-abd8-4d93-b9d7-4586793e9558

Version: 3

Effective Time: 20190801

CVS Pharmacy,Inc.