MedPath

Albuforce

DRUG FACTS:

Approved
Approval ID

dca03511-30a1-44f0-a9e1-8e6be1831aa4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 19, 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.

Equisetum Hyemale, Solidago Virgaurea, Apis Mellifica, Mercurius Corrosivus, Nux Moschata, Phosphorus, Terebinthina

PRODUCT DETAILS

NDC Product Code43857-0572
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateMay 19, 2025
Generic NameEquisetum Hyemale, Solidago Virgaurea, Apis Mellifica, Mercurius Corrosivus, Nux Moschata, Phosphorus, Terebinthina

INGREDIENTS (9)

EQUISETUM HYEMALE WHOLEActive
Quantity: 3 [hp_X] in 1 mL
Code: 59677RXH25
Classification: ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOPActive
Quantity: 3 [hp_X] in 1 mL
Code: 5405K23S50
Classification: ACTIB
MERCURIC CHLORIDEActive
Quantity: 12 [hp_X] in 1 mL
Code: 53GH7MZT1R
Classification: ACTIB
NUTMEGActive
Quantity: 12 [hp_X] in 1 mL
Code: AEE24M3MQ9
Classification: ACTIB
PHOSPHORUSActive
Quantity: 12 [hp_X] in 1 mL
Code: 27YLU75U4W
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
APIS MELLIFERAActive
Quantity: 12 [hp_X] in 1 mL
Code: 7S82P3R43Z
Classification: ACTIB
TURPENTINE OILActive
Quantity: 12 [hp_X] in 1 mL
Code: C5H0QJ6V7F
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PACKAGE LABEL DISPLAY

BIOActiveNutritional

ALBUFORCE

HOMEOPATHIC

1 FL OZ (30 ml)

ALBUFORCE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/19/2025

USES:

For temporary relief of minor burning and soreness upon urination, mild pain in the region of the right kidney, swelling of the legs, and scanty urination.**

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/19/2025

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: 5/23/2025

ACTIVE INGREDIENTS:

Apis Mellifica 12X, Equisetum Hyemale 3X, Mercurius Corrosivus 12X, Nux Moschata 12X, Phosphorus 12X, Solidago Virgaurea 3X, Terebinthina 12X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/19/2025

PURPOSE:

Apis Mellifica – symptoms of infections,** Equisetum Hyemale – swelling,** Mercurius Corrosivus – pelvic pain,** Nux Moschata – abdominal bloating,** Phosphorus – back pain,** Solidago Virgaurea – lower back & leg pain,** Terebinthina – kidney support**

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

WARNINGS SECTION

LOINC: 34071-1Updated: 5/19/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/19/2025

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: 5/19/2025

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: 5/19/2025

QUESTIONS:

Demineralized Water, 25% Ethanol

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Albuforce - FDA Drug Approval Details