FDA Label for Sore Throat

View Indications, Usage & Precautions

Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Apotheca Company. 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



ACTIVE INGREDIENTS:  Echinacea purpurea 2X, Plantago major 2X, Baptisia tinctoria 3X, Phytolacca decandra 3X, Apil mellifica 12X, Belladonna 12X, Lachesis mutus 12X, Mercurius solubilis 12X, Hepar sulphuris calcareum 15X.


Otc - Purpose



INDICATIONS:  For the symptomatic relief of monor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.


Warnings



WARNINGS:  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.  Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.




WARNING:  Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult a physician promptly.  Do not use more that two days or administer to children under 3 years of age unless directed by a physician.



Recommended for Professional Use.


Dosage & Administration



DIRECTIONS:  Adults and children over 12 years of age, at onset of symptoms, spray throat every 3 hours.  Consult a physician for use in children under 12 years of age.

To be used according to standard homeopathic indications or as directed by a homeopathic physician.


Inactive Ingredient



INACTIVE INGREDIENTS:  Demineralized water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow flavor, Menthol, Spearmint oil, Stevia 90% Powered Extract, Teaberry oil.



Otc - Questions



Manufactured Exclusively For:

NSI and Nova Aurora Corp

Pittsburgh, PA 15209

www.phpltd.com


Package Label.Principal Display Panel



PROFESSIONAL HEALTH PRODUCTS

SORE THROAT SPRAY

HOMEOPATHIC

C63 (reorder code)

NET 1 FL. OZ. (30 ML)


* Please review the disclaimer below.