Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 7e573986-60c2-40df-9e28-e7f1d9fe1a99
Route
ORAL
Published
Effective Date 2025-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Trifolium Pratense Flower (4 [hp_X]) Phytolacca Americana Root (12 [hp_X]) Calcium Cation Potassium Cation Nitric Acid Phosphoric Acid Sulfur
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-07-31
Description

Calcarea Iodata 12X, Echinacea 3X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Sulphur 12X, Trifolium Pratense 3X.

Purpose

Calcarea Iodata – head congestion,** Echinacea – sore throat,** Kali Muriaticum - fever,** Nitricum Acidum - fatigue,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – throat pain,** Sulphur - inflammation,** Trifolium Pratense – fever** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Medication Information

Purpose

Calcarea Iodata – head congestion,** Echinacea – sore throat,** Kali Muriaticum - fever,** Nitricum Acidum - fatigue,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – throat pain,** Sulphur - inflammation,** Trifolium Pratense – fever** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

Calcarea Iodata 12X, Echinacea 3X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Sulphur 12X, Trifolium Pratense 3X.

Uses:

For temporary relief of swellings with heat and inflammation, and sore throat.**

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

Purpose:

Calcarea Iodata – head congestion,** Echinacea – sore throat,** Kali Muriaticum - fever,** Nitricum Acidum - fatigue,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – throat pain,** Sulphur - inflammation,** Trifolium Pratense – fever**

**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:

Calcarea Iodata 12X, Echinacea 3X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Sulphur 12X, Trifolium Pratense 3X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActiveNutritional

DRAINAGE

HOMEOPATHIC

1 fl. oz. (30mL)

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 swellings with heat and inflammation, and sore throat.**

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

Purpose: (PURPOSE:)

Calcarea Iodata – head congestion,** Echinacea – sore throat,** Kali Muriaticum - fever,** Nitricum Acidum - fatigue,** Phosphoricum Acidum - fatigue,** Phytolacca Decandra – throat pain,** Sulphur - inflammation,** Trifolium Pratense – fever**

**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:)

Calcarea Iodata 12X, Echinacea 3X, Kali Muriaticum 12X, Nitricum Acidum 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 4X, Sulphur 12X, Trifolium Pratense 3X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActiveNutritional

DRAINAGE

HOMEOPATHIC

1 fl. oz. (30mL)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:03.307847 · Updated: 2026-03-14T23:17:22.861881