Label: AMORAY PREMIUM VAPORIZING INHALER- menthol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 31, 2016

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Menthol 50% ................... Nasal Decongestant

    camphor 13% .................. Nasal Decongestant

  • Purpose

    Nasal Decongestant

  • INDICATIONS:

    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 AN INCREASED IN NASAL DISCHARGE may occur.
    • THE USE OF THIS CONTAINER BY MORE THAN ONE PERSON MAY SPREAD INFECTION.
    • DO NOT USE THIS PRODUCT FOR MORE THAN 7 DAY. USE ONLY AS DISRECTED.
    • FREQUENT OR PROLONGED USE MAY CAUSE NASAL CONGESTION TO RECUR OR WORSEN.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. if swallowed, get medical help or contact a Poision Control Center right away.

  • DIRECTIONS:

    • THE PRODUCT DELIVERS IN EACH 800ML OF AIR 0.04 TO 0.150 MG OF LEVMETAMFETAMINE.
    • Do not use more often than 2 hours.

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: 2 INHALATIONS IN EACH NOSTRIL.

    CHILDREN 6 TO 12 YEARS OF AGE (WITH ADULT SUPERVISION): 1 INHALATION IN EACH NOSTRIL.

    CHILDREN UNDER 6 YEARS OF AGE: CONSULT A DOCTOR.

    Childre nuder 2 years of age: DO NOT USE.

  • Inactive Ingredients:

    BUMYL ACETATE, EUCALYTUS OIL, LAVENDER OIL, MENTHE

  • OTHER SAFETY INFORMATION

    THIS INHALER IS EFFECTIVE FOR A MINIMUM OF 3 MONTHS AFTER FIRST USE. KEEP INHALER TIGHTLY CLOSED AND STORE AT 59-86 F (15-30 C )

  • PRINCIPAL DISPLAY PANEL

    Inhaler label

  • INGREDIENTS AND APPEARANCE
    AMORAY PREMIUM VAPORIZING INHALER 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-800
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)13 mg
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A) 50 mg
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    BORNYL ACETATE (UNII: 213431586X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40104-800-01198 in 1 INHALER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/2016
    Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-800)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!