NDC 0067-2086 4 Way Fast Acting

Phenylephrine Hydrochloride

NDC Product Code 0067-2086

NDC 0067-2086-01

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 29.6 mL in 1 BOTTLE, SPRAY

NDC Product Information

4 Way Fast Acting with NDC 0067-2086 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of 4 Way Fast Acting is phenylephrine hydrochloride. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

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.

4 Way Fast Acting 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 10 mg/mL

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • WATER (UNII: 059QF0KO0R)

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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
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: 01-01-2010 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: 12-31-2020 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’.

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Information for Patients

Phenylephrine Nasal Spray

Phenylephrine Nasal Spray is pronounced as (fen il ef' rin)

Why is phenylephrine nasal spray medication prescribed?
Phenylephrine 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. Phenyle...
[Read More]

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4 Way Fast Acting 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 Ingredient

Phenylephrine Hydrochloride 1%

Purpose

Nasal Decongestant

Uses

  • Temporarily relieves nasal congestion due to: •common cold •hay fever •upper respiratory allergies

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 more than 3 days •use only as directed •frequent or prolonged use may cause nasal congestion to recur or worsen •temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur •infection may spread if this container is used by more than one person

Stop Use And Ask A Doctor If

Symptoms persist

If Pregnant Or Breast-Feeding,

Ask a health care professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • •adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 4 hours •children under 12 years of age: ask a doctor •Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other Information

  • •store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

Benzalkonium chloride solution, boric acid, purified water, sodium borate

Principal Display

  • NDC 0067-2086-014 wayFast ActingPhenylephrine Hydrochloride 1%Nasal DecongestantFast Relief of:1.Nasal Congestion2.Swollen Nasal Membranes3.Sinus Congestion4.Sinus PressureNasal Spray1 fl oz (29.6 mL) DO NOT USE IF PERFORATED OVERWRAP PRINTED WITH GSKLOGO AROUND THE CAP OR BOTTLE IS BROKEN OR MISSING1-855-221-5428Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059©2017 GSK group of companies or its licensor.13183Made in Canada

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