Label: FLUENDZ- asafoetida, astragalus menziesii, illicium anisatum, lonicera zylosteum spray

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 8, 2010

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  • 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.
  • 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
    Fluendz Label
  • 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
  • INGREDIENTS AND APPEARANCE
    FLUENDZ 
    asafoetida, astragalus menziesii, illicium anisatum, lonicera zylosteum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50367-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA3 [hp_X]  in 20 mL
    ASTRAGALUS NUTTALLII LEAF (UNII: NC1P15G4KZ) (ASTRAGALUS NUTTALLII LEAF - UNII:NC1P15G4KZ) ASTRAGALUS NUTTALLII LEAF6 [hp_X]  in 20 mL
    STAR ANISE (UNII: XKC1657P78) (STAR ANISE - UNII:XKC1657P78) STAR ANISE1 [hp_X]  in 20 mL
    LONICERA XYLOSTEUM FRUIT (UNII: C21POX0M8J) (LONICERA XYLOSTEUM FRUIT - UNII:C21POX0M8J) LONICERA XYLOSTEUM FRUIT6 [hp_X]  in 20 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50367-100-0120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/15/2010
    Labeler - Herbology International LLC (832910389)
    Registrant - Herbology International LLC (832910389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbology International LLC832910389relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Naturale Inc.844330915manufacture
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