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 (pratensis), silicea, sinusitisinum, pantothenic acid liquid 
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:

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 (Pratensis) 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)

Sinus Tonic

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 (pratensis), silicea, sinusitisinum, pantothenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0532
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT3 [hp_X]  in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE4 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE6 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P) MERCURIC IODIDE12 [hp_X]  in 1 mL
MERCURIC SULFIDE (UNII: ZI0T668SF1) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC SULFIDE12 [hp_X]  in 1 mL
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5) SINUSITISINUM30 [hp_X]  in 1 mL
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID28 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0532-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/02/2020
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0532) , api manufacture(43857-0532) , label(43857-0532) , pack(43857-0532)

Revised: 1/2020
Document Id: ffe67390-bcc1-484d-823a-ce2c7d314b45
Set id: 63234fdc-7456-42c6-8996-fef372dd4a53
Version: 1
Effective Time: 20200102
 
BioActive Nutritional, Inc.