Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 63234fdc-7456-42c6-8996-fef372dd4a53
Route
ORAL
Published
Effective Date 2025-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (1 [hp_X]) Baptisia Tinctoria Root (3 [hp_X]) Thiamine Ion (4 [hp_X]) Goldenseal (5 [hp_X]) Pyridoxine (6 [hp_X]) Spongia Officinalis Skeleton, Roasted (12 [hp_X]) Apis Mellifera (30 [hp_X]) Ascorbic Acid (28 [hp_C]) Calcium Sulfide Dichromate Ion Lachesis Muta Venom Mercuric Iodide Mercuric Cation Pulsatilla Pratensis Whole Silicon Dioxide Sinusitisinum Pantothenic Acid
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-01-02

Description

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

Purpose

Apis Mellifica - swelling,** Ascorbic Acid – anti-oxidant,** Baptisia Tinctoria – flu like symptoms,** Echinacea – sore throat,** Hepar Sulphuris Calcareum – swollen joints,** Hydrastis Canadensis – post nasal drip,** Kali Bichromicum - congestions,** Lachesis Mutus – anti-inflammatory,** Mercurius Iodatus Ruber – sore throat,** Mercurius Sulphuratus Ruber - congestions,** Pantothenic Acid – lung support,** Pulsatilla – ear infection,** Pyridoxinum Hydrochloricum – night sweats,** Silicea - fatigue,** Sinusitisinum – nasal congestion,** Spongia Tosta – dry cough,** Thiaminum, Hydrochloricum – low energy** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Apis Mellifica - swelling,** Ascorbic Acid – anti-oxidant,** Baptisia Tinctoria – flu like symptoms,** Echinacea – sore throat,** Hepar Sulphuris Calcareum – swollen joints,** Hydrastis Canadensis – post nasal drip,** Kali Bichromicum - congestions,** Lachesis Mutus – anti-inflammatory,** Mercurius Iodatus Ruber – sore throat,** Mercurius Sulphuratus Ruber - congestions,** Pantothenic Acid – lung support,** Pulsatilla – ear infection,** Pyridoxinum Hydrochloricum – night sweats,** Silicea - fatigue,** Sinusitisinum – nasal congestion,** Spongia Tosta – dry cough,** Thiaminum, Hydrochloricum – low energy** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

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

Uses:

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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose:

Apis Mellifica - swelling,** Ascorbic Acid – anti-oxidant,** Baptisia Tinctoria – flu like symptoms,** Echinacea – sore throat,** Hepar Sulphuris Calcareum – swollen joints,** Hydrastis Canadensis – post nasal drip,** Kali Bichromicum - congestions,** Lachesis Mutus – anti-inflammatory,** Mercurius Iodatus Ruber – sore throat,** Mercurius Sulphuratus Ruber - congestions,** Pantothenic Acid – lung support,** Pulsatilla – ear infection,** Pyridoxinum Hydrochloricum – night sweats,** Silicea - fatigue,** Sinusitisinum – nasal congestion,** Spongia Tosta – dry cough,** Thiaminum, Hydrochloricum – low energy**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions:

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients:

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

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

SINUS TONIC

HOMEOPATHIC

2fl. oz. (60mL)

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

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.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Purpose: (PURPOSE:)

Apis Mellifica - swelling,** Ascorbic Acid – anti-oxidant,** Baptisia Tinctoria – flu like symptoms,** Echinacea – sore throat,** Hepar Sulphuris Calcareum – swollen joints,** Hydrastis Canadensis – post nasal drip,** Kali Bichromicum - congestions,** Lachesis Mutus – anti-inflammatory,** Mercurius Iodatus Ruber – sore throat,** Mercurius Sulphuratus Ruber - congestions,** Pantothenic Acid – lung support,** Pulsatilla – ear infection,** Pyridoxinum Hydrochloricum – night sweats,** Silicea - fatigue,** Sinusitisinum – nasal congestion,** Spongia Tosta – dry cough,** Thiaminum, Hydrochloricum – low energy**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings: (WARNINGS:)

Sore Throat Warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

Directions: (DIRECTIONS:)

• 10 drops orally, 3 times a day.

• Consult a health care professional for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

SINUS TONIC

HOMEOPATHIC

2fl. oz. (60mL)

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.


Advanced Ingredient Data


Raw Label Data

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