SORE THROAT  - echinacea purpurea, plantago major, baptisia tinctoria spray 
Apotheca Company

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.

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Sore Throat Spray

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.

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

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.

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 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.


Manufactured Exclusively For:

NSI and Nova Aurora Corp

Pittsburgh, PA 15209

www.phpltd.com

PROFESSIONAL HEALTH PRODUCTS

SORE THROAT SPRAY

HOMEOPATHIC

C63 (reorder code)

NET 1 FL. OZ. (30 ML)

Sore Throat Spray

SORE THROAT  
echinacea purpurea, plantago major, baptisia tinctoria spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0157
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR2 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CLOVE (UNII: K48IKT5321)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
MYRRH (UNII: JC71GJ1F3L)  
SAGE (UNII: 065C5D077J)  
THYME (UNII: CW657OBU4N)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
SPEARMINT OIL (UNII: C3M81465G5)  
STEVIA LEAF (UNII: 6TC6NN0876)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMARSHMALLOW (Marshmallow flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57520-0157-130 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/25/2010
Labeler - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture

Revised: 6/2010
Document Id: c8b67091-950b-477e-9a6a-268704b521d3
Set id: 5276bc49-c405-4375-b6e5-2d9a7afa95f4
Version: 2
Effective Time: 20100629
 
Apotheca Company