THROAT FORMULA- baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray
BioActive Nutritional, Inc.

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:

Baptisia Tinctoria 3X, Phytolacca Decandra 4X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.

INDICATIONS:

For temporary relief of swollen tonsils, throat pain and burning of the throat.

WARNINGS:

If pregnant or breast-feeding, ask a health care 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.

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:

Spray orally 4-6 times daily. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of swollen tonsils, throat pain and burning of the throat.

INACTIVE INGREDIENTS:

Clove, Sage, Thyme, Myrrh, Goldenseal, Demineralized Water, 19% Ethanol, Glycerin, Menthol Crystals.

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

THROAT SPRAY FORMULA

HOMEOPATHIC

2 FL OZ (60 ml)

Throat Spray Formula

THROAT FORMULA
baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0484
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y)	BAPTISIA TINCTORIA	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X] in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	12 [hp_X] in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CLOVE (UNII: K48IKT5321)
SAGE (UNII: 065C5D077J)
THYME (UNII: CW657OBU4N)
MYRRH (UNII: JC71GJ1F3L)
GOLDENSEAL (UNII: ZW3Z11D0JV)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0484-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/15/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/15/2018

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0484) , api manufacture(43857-0484) , label(43857-0484) , pack(43857-0484)