PYCNOGENOL 6X- not applicable liquid

PYCNOGENOL by

Drug Labeling and Warnings

PYCNOGENOL 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:

Pycnogenol 6X

INDICATIONS:

For temporary relief of symptoms of hay fever; capillary wall fragile with rupture; capillary wall leakage; rhinitis.

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.

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 symptoms of hay fever; capillary wall fragile with rupture; capillary wall leakage; rhinitis.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY

BioActive Homeopathic

PYCNOGENOL 6X

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

PYCNOGENOL  6X
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0277
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MARITIME PINE (UNII: 50JZ5Z98QY) (MARITIME PINE - UNII:50JZ5Z98QY)	MARITIME PINE	6 [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: 43857-0277-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2014

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0277) , api manufacture(43857-0277) , label(43857-0277) , pack(43857-0277)