NDC 69842-443 Extra Strength Nasal

Phenylephrine Hydrochloride

NDC Product Code 69842-443

NDC 69842-443-30

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Extra Strength Nasal with NDC 69842-443 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Extra Strength Nasal is phenylephrine hydrochloride. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Cvs Pharmacy

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Extra Strength Nasal Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.
  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cvs Pharmacy
Labeler Code: 69842
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-21-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Extra Strength Nasal Product Label Images

Extra Strength Nasal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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 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

  • ▪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

  • NDC 69842-443-30Compare to the active ingredient in Extra Strength Neo-Synephrine®*Extra StrengthNasal SprayPhenylephrine hydrochloride 1.0 %Nasal DecongestantNON-DROWSYCOLD+ALLERGYNasal Congestion RELIEFYou can use every 4 hoursFast Relief Of: Sinus Congestion & Pressure Colds, Allergies 1 FL OZ (30 mL)*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 missingDistributed by:* This product is not manufactured or distributed by Foundation Consumer Healthcare LLC owner of the registered trademark Neo-Synephrine® Extra Strength.

* Please review the disclaimer below.