Vapor Inhaler
FDA Label NDC 50804-281

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc. for the product Vapor Inhaler (NDC 50804-281). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per inhaler), purpose, use, when using this product, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Inhaler)

Levmetamfetamine 50 mg

Purpose

Nasal decongestant

Use

for temporary relief of nasal congestion due to:

  • the common cold
  • hay fever or upper respiratory allergies

When Using This Product

  • do not exceed recommended dosage
  • temporary burning, stinging, sneezing, or increased nasal discharge may occur
  • use of this container by more than one person may spread infection

Otc - Do Not Use

  • do not use for more than 7 days
  • use only as directed
  • frequent or prolonged use may cause nasal congestion to recur or worsen

Otc - Stop Use

Stop use and ask a doctor if symptoms persist

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 levmetamfetamine
  • do not use more often than every 2 hours
    • adults and children 12 years of age and over 2 inhalations in each nostril
    children 6 to under 12 years of age (with adult supervision) 1 inhalation in each nostril
    children under 6 years of age ask a doctor
    children under 2 years of age do not use

Other Information

  • this inhaler is effective for a minimum of 3 months after first use
  • keep inhaler tightly closed
  • store at 59°-86° F (15°-30° C)

Inactive Ingredients

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

Questions Or Comments?

1-866-696-0957

Principal Display Panel - 198 Mg Blister Pack Label

GOODSENSE®

NDC 50804-281-07

Nasal Decongestant

Vapor Inhaler

Levmetamfetamine • Nasal Decongestant

Temporary Relief of
Nasal Congestion due to:

  • Colds • Hay Fever
  • Upper Respiratory Allergies

    • NET WT
    .007 oz (198 mg)

    *Compare to active ingredient of
    Vicks® Vapolnhaler®

    100%
    SATISFACTION
    GUARANTEED

    Principal Display Panel (198 mg Blister Pack Label)

    Principal Display Panel (198 mg Blister Pack Label)

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