NDC 0363-2021 Severe Anefrin

Oxymetazoline Hydrochloride

NDC Product Code 0363-2021

NDC 0363-2021-15

Package Description: 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY > 15 mL in 1 BOTTLE, SPRAY

NDC Product Information

Severe Anefrin with NDC 0363-2021 is a a human over the counter drug product labeled by Walgreens. The generic name of Severe Anefrin is oxymetazoline hydrochloride. The product's dosage form is liquid and is administered via nasal form.

Labeler Name: Walgreens

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Severe Anefrin 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.

  • OXYMETAZOLINE HYDROCHLORIDE .05 g/15mL

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MENTHOL, (+)- (UNII: C6B1OE8P3W)
  • PEG-6 STEARATE (UNII: 8LQC57C6B0)
  • CAMPHOR, (-)- (UNII: 213N3S8275)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

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.

Product Labeler Information

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

Labeler Name: Walgreens
Labeler Code: 0363
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: 02-08-2021 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: 12-31-2022 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.

Severe Anefrin 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

Oxymetazoline hydrochloride 0.05%

Warnings 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 nasla congestion to recur or worsen. • temporary discomfort such as burning, stinging, sneezing or an increase in nasla discharge may occur • 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.

Directions

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor

To Use:

Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counterclockwise. Before using the firsst time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumn at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

Distributed By: Walgreens Co. 200 Wilmot Rd., Deerfield, Il 60015

100% SATISFACTION GUARANTEEDwalgreens.com ©2020 Walgreen Co.

Inactive Ingredients

Benzalkonium Chloride Solution, Camphor, CArboxymethyl Cellulose Sodium, Cellulose Gum, Disodium EDTA, Disodium Phosphate, Eucalyptol, Glycerin, Menthol, Microcrystalline Cellulose, PEG-6, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic

Uses

• temporarily relives nasak congestions due to:• common cold • hay fever • upper respiratory allergies• temporarily relieves sinus congestgions and pressure• shrinks swollen nasal membranes so you can breath more freely

Purpose

Nasal Decongestant

Severe Anefrin Nasal Spray

NO DRIPMAXIMUM STRENGTH12 HOUR+ MENTHOL

* Please review the disclaimer below.