SORE THROAT- echinacea purpurea, plantago major, baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis m

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98), PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U), BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU), PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG), APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z), ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), LACHESIS MUTA VENOM (UNII: VSW71SS07I)
Available from:
Nova Aurora Corp
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores. For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.
Authorization status:
unapproved homeopathic
Authorization number:
53173-0001-1

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.

----------

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

echinacea purpurea, plantago major, baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis

mutus, mercurius solubilis, hepar sulphuris calcareum spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53173-0 0 0 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ECHINACEA PURPUREA (UNII: QI7G114Y9 8 ) (ECHINACEA PURPUREA -

UNII:Q I7G114Y9 8 )

ECHINACEA PURPUREA

2 [hp_X]

in 1 mL

PLANTAGO MAJO R (UNII: W246 9 WNO6 U) (PLANTAGO MAJOR - UNII:W246 9 WNO6 U)

PLANTAGO MAJOR

2 [hp_X]

in 1 mL

BAPTISIA TINCTO RIA RO O T (UNII: 5EF0 HWI5WU) (BAPTISIA TINCTORIA ROOT -

UNII:5EF0 HWI5WU)

BAPTISIA TINCTORIA

ROOT

3 [hp_X]

in 1 mL

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA AMERICANA

ROOT - UNII:11E6 VI8 VEG)

PHYTOLACCA

AMERICANA ROOT

3 [hp_X]

in 1 mL

APIS MELLIFERA (UNII: 7S8 2P3R43Z) (APIS MELLIFERA - UNII:7S8 2P3R43Z)

APIS MELLIFERA

12 [hp_X]

in 1 mL

ATRO PA BELLADO NNA (UNII: WQZ3G9 PF0 H) (ATROPA BELLADONNA -

UNII:WQZ3G9 PF0 H)

ATROPA BELLADONNA

12 [hp_X]

in 1 mL

LACHESIS MUTA VENO M (UNII: VSW71SS0 7I) (LACHESIS MUTA VENOM -

UNII:VSW71SS0 7I)

LACHESIS MUTA VENOM

12 [hp_X]

in 1 mL

MERCURIUS SO LUBILIS (UNII: 324Y40 38 G2) (MERCURIUS SOLUBILIS -

UNII:324Y40 38 G2)

MERCURIUS SOLUBILIS

12 [hp_X]

in 1 mL

CALCIUM SULFIDE (UNII: 1MBW0 7J51Q) (CALCIUM SULFIDE - UNII:1MBW0 7J51Q)

CALCIUM SULFIDE

15 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CLO VE (UNII: K48 IKT5321)

GO LDENSEAL (UNII: ZW3Z11D0 JV)

MYRRH (UNII: JC71GJ1F3L)

SAGE (UNII: 0 6 5C5D0 77J)

THYME (UNII: CW6 57OBU4N)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

MENTHO L (UNII: L7T10 EIP3A)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

STEVIA REBAUDIUNA LEAF (UNII: 6 TC6 NN0 8 76 )

SPEARMINT O IL (UNII: C3M8 146 5G5)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

MARSHMALLOW

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:53173-0 0 0 1-

30 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

Nova Aurora Corp

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

10 /0 9 /20 15

Labeler -

Nova Aurora Corp (032439395)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(53173-0 0 0 1) , api manufacture(53173-0 0 0 1) , label(53173-0 0 0 1) , pack(53173-

0 0 0 1)

Revised: 10/2015

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