Label: THERAMAX ALLERGY RELIEF NASAL- camellia sinensis, allium cepa, natrum muriaticum, nux vomica, luffa operculata, galphimia glauca, histaminum hydrochlorum, 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                                           Upper respiratory allergy symptom relief

    Allium Cepa 6X                                                   Upper respiratory allergy symptom relief

    Natrum Muriaticum 6X                                    Upper respiratory allergy symptom relief

    Nux Vomica 6X                                                 Upper respiratory allergy symptom relief

    Luffa Oprculata 6X, 12X, 30X                           Upper respiratory allergy symptom relief

    Galphimia Glauca 12X, 30X                                Upper respiratory allergy symptom relief

    Histaminum Hydrochloricum 12X, 30X, 200X   Upper respiratory allergy symptom relief

    Sulphur 12X, 30X, 200X                                          Upper respiratory allergy symptom relief

  • PURPOSE

    Purpose:

    Upper respiratory allergy symptom relief

  • INDICATIONS & USAGE

    Uses

    Relieves symptoms of hay fever and other upper respiratory allergies such as:

    sneezing   runny nose   itchy, watery eyes   nasal congestion   sinus pressure

  • WARNINGS

    Warnings

    For nasal use only.

  • ASK DOCTOR

    Ask a doctor before use if you have

    ear nose or throat sensitivity

    susceptibility 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 or 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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    For best results, use at the first sign of allergy 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 time, prime pump by depressing several times.

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

    While inside nasal opening, slightly angle nozzle outward.

    Pump one to two 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, glycerin, hydroxyethylcellulose, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic, water

  • PRINCIPAL DISPLAY PANEL

    THERAMAX   NDC 51445-201-15

    Seasonal Allergy Relief

    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)

    (c)2008 Product of USA

    HOMEOPATHIC



    THERAMAX

    ALLERGY RELIEF

    ZINC FREE

    NASAL SPRAY



    Relief of

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Nasal Congestion

    Sinus Pressure

    0.50 FL OZ (15ml) Homeopathic



    DIRECTIONS

    1. Remove cap and safety clip

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

    3. Prior to initial use, prime pump by holding it upright and depressing several times (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.



    HOMEOPATHIC

  • PRINCIPAL DISPLAY PANEL

    Active Ingredients:

    Camellia Sinensis 3X, Allium cepa 6X

    Natrum Muriaticum 6X, Nux vornica 6X

    Luffa Operculata 6X, 12X, 30X

    Galphimia Glauca 12X, 30X

    Histaminum Hydrochloricum 12X, 30X, 200X

    Sulphur 12X, 30X, 200X



    Note: Prior to using Theramax Allergy Relief, read the entire package

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

    New York, NY 10005

    www.theramaxrelief.com

    PRODUCT OF USA



    Theramax

    Allergy Relief

    Zinc Free

    Nasal Spray

    0.50 FL OZ.  (15ml)       HOMEOPATHIC



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

    Uses: Relieves symptoms of hay fever and other respiratory allergies such as, sneezing, runny nose, itchy watery eyes, nasal congestion and sinus pressure.



    Questions or comments: Call 866-284-9561

  • PRINCIPAL DISPLAY PANEL

    Theramax Allergy label 1

  • PRINCIPAL DISPLAY PANEL

    Theramax Allergy label2

  • INGREDIENTS AND APPEARANCE
    THERAMAX ALLERGY RELIEF NASAL 
    camellia sinensis, allium cepa, natrum muriaticum, nux vomica, luffa operculata, galphimia glauca, histaminum hydrochlorum, sulphur spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51445-201
    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
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 15 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6 [hp_X]  in 15 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 15 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 15 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP12 [hp_X]  in 15 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [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:51445-201-151 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, INC.016437738manufacture