DRAINAGE- echinacea (angustifolia), trifolium pratense, phytolacca decandra, calcarea iodata, kali muriaticum, nitricum acidum, phosphoricum acidum, sulphur iodatum liquid
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

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

INDICATIONS:

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

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 cool, dry place.

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

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.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

DRAINAGE

HOMEOPATHIC

1 FL OZ (30 ml)

Drainage

DRAINAGE
echinacea (angustifolia), trifolium pratense, phytolacca decandra, calcarea iodata, kali muriaticum, nitricum acidum, phosphoricum acidum, sulphur iodatum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0489
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X] in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM IODIDE	12 [hp_X] in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CATION	12 [hp_X] in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0)	SULFUR IODIDE	12 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0489-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/02/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/02/2018

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0489) , api manufacture(43857-0489) , label(43857-0489) , pack(43857-0489)