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Drainage

DRUG FACTS:

Approved
Approval ID

7e573986-60c2-40df-9e28-e7f1d9fe1a99

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

BioActive Nutritional, Inc.

DUNS: 624980496

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Echinacea (Angustifolia), Trifolium Pratense, Phytolacca Decandra, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Sulphur

PRODUCT DETAILS

NDC Product Code43857-0642
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 20, 2025
Generic NameEchinacea (Angustifolia), Trifolium Pratense, Phytolacca Decandra, Calcarea Iodata, Kali Muriaticum, Nitricum Acidum, Phosphoricum Acidum, Sulphur

INGREDIENTS (10)

CALCIUM IODIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 8EKI9QEE2H
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 660YQ98I10
Classification: ACTIM
NITRIC ACIDActive
Quantity: 12 [hp_X] in 1 mL
Code: 411VRN1TV4
Classification: ACTIB
PHOSPHORIC ACIDActive
Quantity: 12 [hp_X] in 1 mL
Code: E4GA8884NN
Classification: ACTIB
SULFURActive
Quantity: 12 [hp_X] in 1 mL
Code: 70FD1KFU70
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ECHINACEA ANGUSTIFOLIA WHOLEActive
Quantity: 3 [hp_X] in 1 mL
Code: VB06AV5US8
Classification: ACTIB
TRIFOLIUM PRATENSE FLOWERActive
Quantity: 3 [hp_X] in 1 mL
Code: 4JS0838828
Classification: ACTIB
PHYTOLACCA AMERICANA ROOTActive
Quantity: 4 [hp_X] in 1 mL
Code: 11E6VI8VEG
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

PACKAGE LABEL DISPLAY:

BIOActiveNutritional

DRAINAGE

HOMEOPATHIC

1 fl. oz. (30mL)

DRAINAGE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/20/2025

QUESTIONS:

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

1-800-288-9525

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

ACTIVE INGREDIENTS:

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

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 SECTION

LOINC: 34071-1Updated: 5/20/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2024

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

DIRECTIONS:

• 10 drops orally, 3 times a day.

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2024

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

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Drainage - FDA Drug Approval Details