Fluendz
FDA Label NDC 50367-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Herbology International Llc for the product Fluendz (NDC 50367-100). 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 indications & usage, inactive ingredient, dosage & administration, warnings and precautions, package label.principal display panel, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Indications & Usage

  • For relief of symptoms associated with the flu and common cold as per Homeopathic Materia Medica.

Inactive Ingredient

Inactive Ingredients:   Ascorbic acid, alcohol, purified water and zinum gluconicum

Dosage & Administration

  • Adults and children 12 years and over:  Spray twice under the tongue every 4-5 hours, up to 5 times a day.  For severe symptoms, dosage may be taken up to 6 times the first day.
  • Children 2 to 12 years:  Spray once under the tongue every 4-5 hours, up to 3 times per day.  For severe symptoms, dosage may be taken up to 4 times the first day.
  • Children under 2 years of age:  Consult a doctor prior to use.

Warnings And Precautions

Warnings:

  • Stop use and ask a doctor if symptoms persist for more than 7 days.
  • Do not use if you have an allergy or hypersensitivity to components of the formula.
  • If pregnant or breast feeding ask a health professional before use.
  • Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label.Principal Display Panel

  • No Side Effects
  • Non Drowsy
  • No Interactions with Other Medications


    • Relieves Flu Symptoms:
    • Fever
    • Chills
    • Sore Throat
    • Congestion
    • Cough
    • Vomiting
    • Headache
    • Nausea
    • Body Aches
    • Weakness
    • Running Nose
    • Dizziness

Description

Questions or Comments? 1-877-FLU-1288 Monday through Friday, 9am-5pm or www.FLUEndz.com

Developed, Formulated and Distributed by:
Herbology International
Roseville, California 95661
All rights reserved
U.S. Patents Pending

Manufactured by: Apotheca Inc., Woodbine, IA 51579, 1-800-736-3130

Other Information

  • Store at 20-25 degrees C (68-77 degrees F)
  • Avoid eating 30 minutes before and after taking FLUEndz
  • The letters HPUS imply that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States

* Please review the disclaimer below.