Amoray Premium Vaporizing Inhaler
FDA Label NDC 40104-800

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Pulisi Daily Chemical Products Co.,ltd. for the product Amoray Premium Vaporizing Inhaler (NDC 40104-800). 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 ingredients, purpose, indications:, warnings:, otc - keep out of reach of children, directions:, inactive ingredients:, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - 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 )

Package Label.Principal Display Panel

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