Label: THERABIOGEN COLD AND FLU RELIEF NASAL- camelia sinensis, sambucus nigra, gelsemium sempervirens, bryonia alba, sulphur spray

  • 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 October 6, 2010

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients                                                            Purpose

    Camellia Sinensis    3X                                                           Cold and Flu Symptom Relief

    Sabmucus Nigra 2X                                                                  Cold and Flu Symptom Relief

    Gelsemium sempervirens 6X, 12X 30X                                 Cold and Flu Symptom Relief

    Bryonia alba 6X                                                                     Cold and Flu Symptom Relief

    Sulphur 12X                                                                           Cold and Flu Symptom Relief


  • PURPOSE

    Purpose

    Cold and flu symptom relief

  • INDICATIONS & USAGE

    Uses

    Relieves old and flu symptoms

    Provides relief from upper respiratory symptoms such as nasal and sinus congestion, runny nose, sore throat, sneezing and headache

    Also relieves fever, chills and body aches associated with the flu

  • WARNINGS

    Warnings

    For nasal use only


  • ASK DOCTOR

    Ask a doctor before use if you have

    ear, nose or throat sensitivity

    susceptible to nose bleeds

  • WHEN USING

    When using this product

    Avoid contact with eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.

    The use of this container by more than one person may spread infection.

  • STOP USE

    Stop use and ask a doctor if symptoms persist

  • PREGNANCY OR BREAST FEEDING

    If pregnant of breast feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    For best results, use at the first sign of cold or flu symptoms and continue to use for an additional 48 hours after symptoms subside

    Adults and children 6 years of age and older (with adult supervision):

    Remove cap and safety clip also see illustration on side carton and insert).

    Hold with thumb at bottom of bottle and nozzle between your fingers

    Before using the first tie, prime pump by depressing several times.

    Place tip of nozzle just past nazal opening (approxiately 1/8").

    While inside nasal opening, slightly angle nozzle outward.

    Pump one to tw times into each nostril

    After application, press lightly on outside of each nostril for about 5 seconds.

    Wait at least 30 seconds before blowing nose

    Use once every 4 hours

    Children under 6 years of age: consult a doctor before use.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Benzalkonium chloride, glyerin, hydroxyethylcellulose, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic, water

  • PRINCIPAL DISPLAY PANEL

    Theramax

    Take at the first sign of cold or flu symptoms

    No known drug interactions

    Non-drowsy

    No jitters

    Non-habit forming

    Homeopathic

    Satisfaction guaranteed

    Store at room temperature 15C-29C (59F-84F)

    Product is naturally dark in color

    Questions? Comments?
    call 866-284-9561 or visit us on the web at
    www.theramaxrelief. com

    Developed and distributed by
    Therabiogen, Inc. (OTC: TRAB.OB)
    New York, NY 10005
    (c) 2008 PRODUCT OF USA

    HOMEOPATHIC


    Theramax

    Cold and flu relief

    ZINC FREE

    Nasal Spray

    Relief of:

    Nasal and Sinus Congestion

    Runny Nose

    Sore Throat

    Sneezing

    Chills and Fever

    0.50 fl oz (15 ml) Homeopathic



    TheraMax

    DIRECTIONS

    1.  Remove cap and safety clip

    2. Hold with thumb at bottom and nozzle between your fingers

    3. Prior to initial use, prime pump by holding it upright and depressing several ties (into a tissue) until the liquid is dispensed

    4. Place tip of nozzle just past nasal opening (approximately 1/8")

    5. While inside nasal opening, slightly angle nozzle outward, as shown

    6. Pump one to two times into each nostril

    7. After application, press lightly on the outside of each  nostril for about 5 seconds.

  • PRINCIPAL DISPLAY PANEL

    Active Ingredients:

    Camellia simensis 3X,

    Sambucus nigra 2X

    Gelsemium sempervirens 6X, 12X, 30X

    Bryonica Alba 6X

    Sulphur 12X


    Note: Prior to using TheraMax Cold and Flu Relief, read the entire package

    (c) 2008 Developed and distributed by Therabiogen, Inc. (OTC: TRABE.OB)

    New York, NY 10005

    www.theramaxrelief.com

    PRODUCT OF USA



    TheraMax

    Cold and Flu Relief

    Zinc Free

    Nasal Spary

    0.50 fl oz (15 ml)   Homeopathic



    Do not use if tamper resistant seal is broken or missing.


    Uses: Relieves cold and flu symptoms. Provides relief from upper respiratory symptoms such as nasal and sinus congestion, runny nose, sore throat, sneezing and headach. Also relieves fever, chills, ad body aches associated with the flu.

    Questions or commeents:

    Call 866-284-9561

  • PRINCIPAL DISPLAY PANEL

    Theramax cold and flu relief

  • PRINCIPAL DISPLAY PANEL

    Theramax cold and flu relief2

  • INGREDIENTS AND APPEARANCE
    THERABIOGEN COLD AND FLU RELIEF NASAL 
    camelia sinensis, sambucus nigra, gelsemium sempervirens, bryonia alba, sulphur spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51445-101
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF3 [hp_X]  in 15 mL
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP2 [hp_X]  in 15 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 15 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 15 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51445-101-151 in 1 BOX
    115 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/29/2010
    Labeler - THERABIOGEN (831281733)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMEDX SCIENCE, INC016437738manufacture