POLLEN MIX- american elm, plane (sycamore), ash, beech, willow, elder (box elder), alder, cedar, maple, hazel, poplar, kentucky bluegrass, orchard grass, silver birch, bermuda grass, johnson grass, rye grass, vernal grass, bahia grass, oak, hickory, timothy grass 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:

American Elm 16X, 24X, 30X, Plane (Sycamore) 16X, 24X, 30X, Ash 16X, 24X, 30X, Beech 16X, 24X, 30X, Willow 16X, 24X, 30X, Elder (Box Elder) 16X, 24X, 30X, Alder 16X, 24X, 30X, Cedar 16X, 24X, 30X, Maple 16X, 24X, 30X, Hazel 16X, 24X, 30X, Poplar 16X, 24X, 30X, Kentucky Bluegrass 16X, 24X, 30X, Orchard Grass 16X, 24X, 30X, Silver Birch 16X, 24X, 30X, Bermuda Grass 16X, 24X, 30X, Johnson Grass 16X, 24X, 30X, Rye Grass 16X, 24X, 30X, Vernal Grass 16X, 24X, 30X, Bahia Grass 16X, 24X, 30X, Oak 16X, 24X, 30X, Hickory 16X, 24X, 30X, Timothy Grass 16X, 24X, 30X.

INDICATIONS:

For temporary relief of allergies due to pollen.

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 allergies due to pollen.

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

POLLEN MIX

HOMEOPATHIC

1 FL OZ (30 ml)

Pollen Mix

POLLEN MIX 
american elm, plane (sycamore), ash, beech, willow, elder (box elder), alder, cedar, maple, hazel, poplar, kentucky bluegrass, orchard grass, silver birch, bermuda grass, johnson grass, rye grass, vernal grass, bahia grass, oak, hickory, timothy grass liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0535
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (ULMUS AMERICANA POLLEN - UNII:89BAT511BD) ULMUS AMERICANA POLLEN16 [hp_X]  in 1 mL
PLATANUS X ACERIFOLIA POLLEN (UNII: 77X11O684J) (PLATANUS X ACERIFOLIA POLLEN - UNII:77X11O684J) PLATANUS X ACERIFOLIA POLLEN16 [hp_X]  in 1 mL
FRAXINUS EXCELSIOR POLLEN (UNII: 1824QUA0U3) (FRAXINUS EXCELSIOR POLLEN - UNII:1824QUA0U3) FRAXINUS EXCELSIOR POLLEN16 [hp_X]  in 1 mL
FAGUS SYLVATICA POLLEN (UNII: 63218N1ZBI) (FAGUS SYLVATICA POLLEN - UNII:63218N1ZBI) FAGUS SYLVATICA POLLEN16 [hp_X]  in 1 mL
SALIX X FRAGILIS POLLEN (UNII: UQ7Z2EA3ZI) (SALIX X FRAGILIS POLLEN - UNII:UQ7Z2EA3ZI) SALIX X FRAGILIS POLLEN16 [hp_X]  in 1 mL
SAMBUCUS CANADENSIS FLOWER (UNII: C87P971T6W) (SAMBUCUS CANADENSIS FLOWER - UNII:C87P971T6W) SAMBUCUS CANADENSIS FLOWER16 [hp_X]  in 1 mL
ALNUS RUBRA POLLEN (UNII: Z0F2YK1B7H) (ALNUS RUBRA POLLEN - UNII:Z0F2YK1B7H) ALNUS RUBRA POLLEN16 [hp_X]  in 1 mL
JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (JUNIPERUS VIRGINIANA POLLEN - UNII:PY0JA16R2G) JUNIPERUS VIRGINIANA POLLEN16 [hp_X]  in 1 mL
ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (ACER SACCHARUM POLLEN - UNII:V38QUQ7861) ACER SACCHARUM POLLEN16 [hp_X]  in 1 mL
CORYLUS AVELLANA POLLEN (UNII: CR2J49TL6L) (CORYLUS AVELLANA POLLEN - UNII:CR2J49TL6L) CORYLUS AVELLANA POLLEN16 [hp_X]  in 1 mL
POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (POPULUS ALBA POLLEN - UNII:VU8C8SB23P) POPULUS ALBA POLLEN16 [hp_X]  in 1 mL
POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (POA PRATENSIS POLLEN - UNII:SCB8J7LS3T) POA PRATENSIS POLLEN16 [hp_X]  in 1 mL
DACTYLIS GLOMERATA POLLEN (UNII: 83N78IDA7P) (DACTYLIS GLOMERATA POLLEN - UNII:83N78IDA7P) DACTYLIS GLOMERATA POLLEN16 [hp_X]  in 1 mL
BETULA PENDULA POLLEN (UNII: ZL5TV40C5Y) (BETULA PENDULA POLLEN - UNII:ZL5TV40C5Y) BETULA PENDULA POLLEN16 [hp_X]  in 1 mL
CYNODON DACTYLON POLLEN (UNII: 175F461W10) (CYNODON DACTYLON WHOLE - UNII:2Q8MR21NHK) CYNODON DACTYLON POLLEN16 [hp_X]  in 1 mL
SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (SORGHUM HALEPENSE POLLEN - UNII:577VA5B4HP) SORGHUM HALEPENSE POLLEN16 [hp_X]  in 1 mL
SECALE CEREALE POLLEN (UNII: I6KAZ8AO1O) (SECALE CEREALE POLLEN - UNII:I6KAZ8AO1O) SECALE CEREALE POLLEN16 [hp_X]  in 1 mL
ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (ANTHOXANTHUM ODORATUM POLLEN - UNII:2KIK19R45Y) ANTHOXANTHUM ODORATUM POLLEN16 [hp_X]  in 1 mL
PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (PASPALUM NOTATUM POLLEN - UNII:V003SHB7VK) PASPALUM NOTATUM POLLEN16 [hp_X]  in 1 mL
QUERCUS ROBUR POLLEN (UNII: 4PNW66TTHR) (QUERCUS ROBUR POLLEN - UNII:4PNW66TTHR) QUERCUS ROBUR POLLEN16 [hp_X]  in 1 mL
CARYA GLABRA POLLEN (UNII: KPO1Z9N98A) (CARYA GLABRA POLLEN - UNII:KPO1Z9N98A) CARYA GLABRA POLLEN16 [hp_X]  in 1 mL
PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE TOP - UNII:S7PW24BX20) PHLEUM PRATENSE POLLEN16 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0535-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/29/2019
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0535) , api manufacture(43857-0535) , label(43857-0535) , pack(43857-0535)

Revised: 11/2021
Document Id: ef61abb0-d28b-496e-9f38-61d07ef5b05a
Set id: 8b9fa995-47a4-4b2d-9db8-5f4c6eccbd16
Version: 2
Effective Time: 20211119
 
BioActive Nutritional, Inc.