Theramax Allergy Relief Nasal
FDA Label NDC 51445-201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Therabiogen for the product Theramax Allergy Relief Nasal (NDC 51445-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - 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

Otc - 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.

Otc - Ask Doctor

Ask a doctor before use if you have

ear nose or throat sensitivity

susceptibility 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 or 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 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

Package Label.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

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

Theramax Allergy Label 1 (Allergyrelieflabel)

Theramax Allergy Label 1 (Allergyrelieflabel)

Theramax Allergy Label2 (Allergyreliefbox)

Theramax Allergy Label2 (Allergyreliefbox)

* Please review the disclaimer below.