EXTRA STRENGTH NASAL- phenylephrine hydrochloride spray

Extra Strength Nasal by

Drug Labeling and Warnings

Extra Strength Nasal by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Phenylephrine Hydrochloride 1.0 %

Purpose

Nasal decongestant

Uses

• ▪ temporarily relieves nasal congestion due to:
• ▪ common cold
• ▪ hay fever
• ▪ upper respiratory allergies (allergic rhinitis)
• ▪ temporarily relieves sinus congestion and pressure
• ▪ shrinks swollen membranes so you can breathe more freely
• ▪ temporarily restores freer breathing through the nose

Warnings

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients

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 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

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

• ▪ 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

Inactive ingredients

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

Questions

1-866-467-2748

Principal Display

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

Extra Strength

Nasal Spray

Phenylephrine hydrochloride 1.0 %

Nasal Decongestant

NON-DROWSY

COLD+ALLERGY

Nasal Congestion RELIEF

You can use every 4 hours

Fast Relief Of:

Sinus Congestion & Pressure

•   Colds, Allergies

*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Extra Strength Neo-Synephrine®.

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

Do not use if printed seal over cap is torn or missing

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2021 CVS/pharmacy, CVS.com®

1-800-SHOP CVS V-12431

CVS Quality Money Back guarantee

* This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine® Extra Strength.

Package Label for Extra Strength Nasal Spray

Package Label for Extra Strength Sinus Relief

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH NASAL 
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-443
Route of Administration	NASAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-443-30	1 in 1 CARTON	09/21/2020
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 69842-443-40	1 in 1 CARTON	09/21/2020
2		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/21/2020

Labeler - CVS PHARMACY (062312574)