OTC Medication Information: Extra Strength Nasal

EXTRA STRENGTH NASAL- phenylephrine hydrochloride spray
CVS PHARMACY

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.

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

Extra Strength Nasal Spray
(click image for full-size original)

Package Label for Extra Strength Sinus Relief

Extra Strength Sinus Relief Cold and Allergy Relief
(click image for full-size original)
EXTRA STRENGTH NASAL
phenylephrine hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-443
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
BENZALKONIUM CHLORIDE
BENZYL ALCOHOL
WATER
SODIUM CHLORIDE
SODIUM CITRATE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-443-30 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 30 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (69842-443-30)
2 NDC:69842-443-40 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
2 30 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (69842-443-40)
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)

Revised: 09/2023 CVS PHARMACY

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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