NDC 13709-281 Sinu Inhaler

Levmetamfetamine Nasal Decongestant

NDC Product Code 13709-281

NDC 13709-281-07

Package Description: 1 INHALER in 1 BLISTER PACK > 198 INHALANT in 1 INHALER

NDC Product Information

Sinu Inhaler with NDC 13709-281 is a a human over the counter drug product labeled by Neilmed Pharmaceuticals, Inc.. The generic name of Sinu Inhaler is levmetamfetamine nasal decongestant. The product's dosage form is inhalant and is administered via nasal form.

Dosage Form: Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.

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.

Sinu Inhaler 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.


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.

  • BORNYL ACETATE (UNII: 213431586X)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)

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: Neilmed Pharmaceuticals, Inc.
Labeler Code: 13709
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: 06-15-2014 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sinu Inhaler Product Label Images

Sinu Inhaler 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 (Per Inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use For Temporary Relief Of Nasal Congestion Due To:

  • The common coldhay fever or upper respiratory allergies

When Using This Product

  • Do not exceed recommended dosagetemporary burning, stinging, sneezing, or increased nasal discharge may occuruse of this container by more than one person may spread infectiondo not use for more than 7 daysUse only as directedfrequent or prolonged use may cause nasal congestion to recur or worsen

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

  • The product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetaminedo not use more often than every 2 hoursadults and children 12 years of age and over2 inhalations in each nostrilchildren 6 to under 12 years of age(with adult supervision)1 inhalation in each nostrilchildren under 6 years of ageask a doctorchildren under 2 years of agedo not use

Other Information

  • ​this inhaler is effective for a minimum of 3 months after first usekeep inhaler tightly closedstore at 59​o-86​o​F (15o- 30oC)

Inactive Ingredients:

Bornyl acetate, camphor, lavender oil, menthol, methyl salicylate

* Please review the disclaimer below.