SINUS TONIC (echinacea (angustifolia), baptisia tinctoria, thiaminum hydrochloricum, hydrastis canadensis, pyridoxinum hydrochloricum, spongia tosta, apis mellifica, ascorbic acid, hepar sulphuris calcareum, kali bichromicum, lachesis mutus, mercurius iodatus ruber, mercurius sulphuratus ruber, pulsatilla- vulgaris, silicea, sinusitisinum, pantothenic acid liquid

Sinus Tonic by

Drug Labeling and Warnings

Sinus Tonic by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Echinacea (Angustifolia) 1X, Baptisia Tinctoria 3X, Thiaminum Hydrochloricum 4X, Hydrastis Canadensis 5X, Pyridoxinum Hydrochloricum 6X, Spongia Tosta 6X, Apis Mellifica 12X, Ascorbic Acid 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lachesis Mutus 12X, Mercurius Iodatus Ruber 12X, Mercurius Sulphuratus Ruber 12X, Pulsatilla (Vulgaris) 12X, Silicea 12X, Sinusitisinum 30X, 60X, 200X, Pantothenic Acid 28C.

INDICATIONS:

For temporary relief of redness and swelling of the nasal passages with post nasal drip, thick, yellowish discharge from the nose, foul smell; frequent coryza alternating with stoppage.

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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of redness and swelling of the nasal passages with post nasal drip, thick, yellowish discharge from the nose, foul smell; frequent coryza alternating with stoppage.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

SINUS TONIC

HOMEOPATHIC

2 FL OZ (60 ml)

INGREDIENTS AND APPEARANCE

SINUS TONIC 
echinacea (angustifolia), baptisia tinctoria, thiaminum hydrochloricum, hydrastis canadensis, pyridoxinum hydrochloricum, spongia tosta, apis mellifica, ascorbic acid, hepar sulphuris calcareum, kali bichromicum, lachesis mutus, mercurius iodatus ruber, mercurius sulphuratus ruber, pulsatilla (vulgaris), silicea, sinusitisinum, pantothenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0419
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	4 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X]  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	6 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	6 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	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
MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P)	MERCURIC IODIDE	12 [hp_X]  in 1 mL
MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC SULFIDE	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5)	SINUSITISINUM	30 [hp_X]  in 1 mL
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	28 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0419-1	60 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package	10/28/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/28/2016

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0419) , api manufacture(43857-0419) , label(43857-0419) , pack(43857-0419)