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

  • NDC Code(s): 50367-100-01
  • Packager: Herbology International LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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

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

  • INDICATIONS & USAGE

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

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

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  • 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.
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  • 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.
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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    FLUENDZ 
    asafoetida, astragalus menziesii, illicium anisatum, lonicera zylosteum spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50367-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA 3 [hp_X]  in 20 mL
    ASTRAGALUS NUTTALLII LEAF (UNII: NC1P15G4KZ) (ASTRAGALUS NUTTALLII LEAF - UNII:NC1P15G4KZ) ASTRAGALUS NUTTALLII LEAF 6 [hp_X]  in 20 mL
    STAR ANISE (UNII: XKC1657P78) (STAR ANISE - UNII:XKC1657P78) STAR ANISE 1 [hp_X]  in 20 mL
    LONICERA XYLOSTEUM FRUIT (UNII: C21POX0M8J) (LONICERA XYLOSTEUM FRUIT - UNII:C21POX0M8J) LONICERA XYLOSTEUM FRUIT 6 [hp_X]  in 20 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50367-100-01 20 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/15/2010
    Labeler - Herbology International LLC (832910389)
    Registrant - Herbology International LLC (832910389)
    Establishment
    Name Address ID/FEI Business Operations
    Herbology International LLC 832910389 relabel
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Naturale Inc. 844330915 manufacture
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