SORE THROAT- echinacea purpurea, plantago major, baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray 
Nova Aurora Corp

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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DRUG FACTS:

ACTIVE INGREDIENTS:

Echinacea Purpurea 2X, Plantago Major 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

INDICATIONS:

For the temporary symptomatic relief of minor 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 than two days or administer to children under 3 years of age unless directed by a physician.

Recommended for Professional Use.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

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

INDICATIONS:

For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.

INACTIVE INGREDIENTS:

Demineralized Water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow Flavor, Menthol, Spearmint Oil (flowering tops), Stevia (leaf) Extract, Teaberry Oil Flavor.

QUESTIONS:

Manufactured Exclusively For:

NSI and Nova Aurora Corp

P.O. Box 97227

Pittsburgh, PA 15209

www.phpltd.com

PACKAGE LABEL DISPLAY:

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, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53173-0001
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 SULFIDE - UNII:1MBW07J51Q) 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)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SPEARMINT OIL (UNII: C3M81465G5)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMARSHMALLOWImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53173-0001-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/09/2015
Labeler - Nova Aurora Corp (032439395)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(53173-0001) , api manufacture(53173-0001) , label(53173-0001) , pack(53173-0001)

Revised: 10/2015
Document Id: e057654f-0aa2-45e2-b780-e7306ca53a32
Set id: fc1953c7-2ff3-4909-a2dd-5797988bc270
Version: 1
Effective Time: 20151009
 
Nova Aurora Corp