Vapor Inhaler Inhalant
FDA Label NDC 63868-267

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by C.d.m.a., Inc. for the product Vapor Inhaler (NDC 63868-267). 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  for temporary relief of nasal congestion due to:, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, 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

Warnings

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
  • do not use more than 7 days
  • Use only as directed
  • frequent 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 levmetamfetamine
  • do not use more often than every 2 hours
    • adults and children 12 years of age and over2 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 ageask a doctor
    children under 2 years of agedo not use

Other Information

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

Inactive Ingredients:

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

Questions Or Comments? 248-449-9300

Principal Display Panel - Vapor Inhaler

​QC®

Quality Choice

NDC 63868-267-01

Vapor Inhaler

Nasal Decongestant

Levmetamfetamine | Nasal Decongestant

Temporary Relief of

Nasal Congestion due to:

Colds | Hay Fever

Upper Respiratory Allergies

*Compare to the active ingredient in Vicks®

Vapoinhaler

NET WT .007 oz (198 mg)

* Please review the disclaimer below.