KIDNEY TONIC II (glutathione, kidney (suis), urinary bladder (suis), agrimonia eupatoria flos, apis mellifica, berberis vulgaris, bryonia- alba, calcarea carbonica, galium aparine, rubia tinctorum liquid

Kidney Tonic by

Drug Labeling and Warnings

Kidney Tonic by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Agrimonia Eupatoria, Flos 8X, Apis Mellifica 12X, Berberis Vulgaris 12X, Bryonia (Alba) 12X, Calcarea Carbonica 12X, Galium Aparine 12X, Glutathione 6X, Kidney (Suis) 6X, 12X, 30X, 200X, Rubia Tinctorum 12X, Urinary Bladder (Suis) 6X, 12X, 30X, 200X.

PURPOSE:

Agrimonia Eupatoria, Flos - fever,** Apis Mellifica – symptoms of infection,** Berberis Vulgaris – bladder support,** Bryonia (Alba) – burning urination,** Calcarea Carbonica – back pain,** Galium Aparine – symptoms of infection,** Glutathione - detoxification,** Kidney (Suis) – immune support,** Rubia Tinctorum – urine drainage,** Urinary Bladder (Suis) – support of bladder**

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

USES:

For temporary relief of burning pain in the region of the kidneys, sticking pain in the region of the kidneys, radiating around the abdomen and groin, frequent urination with pain in the thighs and loins.**

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

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:

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

DIRECTIONS:

10 drops orally, 3 times a day or as directed by a health care professional.

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

QUESTIONS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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

1-800-288-9525

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

KIDNEY TONIC II

HOMEOPATHIC

2 fl. oz. (60 mL)

INGREDIENTS AND APPEARANCE

KIDNEY TONIC  II
glutathione, kidney (suis), urinary bladder (suis), agrimonia eupatoria flos, apis mellifica, berberis vulgaris, bryonia (alba), calcarea carbonica, galium aparine, rubia tinctorum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0579
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	6 [hp_X]  in 1 mL
PORK KIDNEY (UNII: X7BCI5P86H) (PORK KIDNEY - UNII:X7BCI5P86H)	PORK KIDNEY	6 [hp_X]  in 1 mL
SUS SCROFA URINARY BLADDER (UNII: 3G7U72W8DA) (SUS SCROFA URINARY BLADDER - UNII:3G7U72W8DA)	SUS SCROFA URINARY BLADDER	6 [hp_X]  in 1 mL
AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (AGRIMONIA EUPATORIA FLOWER - UNII:5811MI029U)	AGRIMONIA EUPATORIA FLOWER	8 [hp_X]  in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	12 [hp_X]  in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	12 [hp_X]  in 1 mL
BRYONIA ALBA WHOLE (UNII: 56K0VVT47P) (BRYONIA ALBA WHOLE - UNII:56K0VVT47P)	BRYONIA ALBA WHOLE	12 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]  in 1 mL
GALIUM APARINE WHOLE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE WHOLE	12 [hp_X]  in 1 mL
RUBIA TINCTORUM ROOT (UNII: 0SVP95L23G) (RUBIA TINCTORUM ROOT - UNII:0SVP95L23G)	RUBIA TINCTORUM ROOT	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0579-1	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/18/2021

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0579) , api manufacture(43857-0579) , label(43857-0579) , pack(43857-0579)