FDA Label for Therabiogen Cold And Flu Relief Nasal

View Indications, Usage & Precautions

Therabiogen Cold And Flu Relief Nasal Product Label

The following document was submitted to the FDA by the labeler of this product Therabiogen. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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



Otc - 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



Otc - Ask Doctor



Ask a doctor before use if you have

ear, nose or throat sensitivity

susceptible to nose bleeds


Otc - 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.


Otc - Stop Use



Stop use and ask a doctor if symptoms persist


Otc - Pregnancy Or Breast Feeding



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


Otc - 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


Package Label.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.

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


* Please review the disclaimer below.