Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

GRAIN AND SEED ANTIGENS- barley, oats, wheat, rice, rye, millet, soybean, corn, milo, bamboo, cotton seed, flax seed, safflower, sesame, sunflower, poppy seed, sorghum, sugarcane, arsenicum album, lycopodium clavatum, natrum muriaticum, sulphur 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

Barley 9X, 12X, 15X, 30X, Oats 9X, 12X, 15X, 30X, Wheat 9X, 12X, 15X, 30X, Rice 9X, 12X, 15X, 30X, Rye 9X, 12X, 15X, 30X, Millet 9X, 12X, 15X, 30X, Soybean 9X, 12X, 15X, 30X, Corn 9X, 12X, 15X, 30X, Milo 9X, 12X, 15X, 30X, Bamboo 9X, 12X, 15X, 30X, Cotton Seed 9X, 12X, 15X, 30X, Flax Seed 9X, 12X, 15X, 30X, Safflower 9X, 12X, 15X, 30X, Sesame 9X, 12X, 15X, 30X, Sunflower 9X, 12X, 15X, 30X, Poppy Seed 9X, 12X, 15X, 30X, Sorghum 9X, 12X, 15X, 30X, Sugarcanes 9X, 12X, 15X, 30X, Arsenicum Album 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Sulphur 12X.

INDICATIONS

For the relief of allergies due to grain and seeds.

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.

DIRECTIONS

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

INACTIVE INGREDIENTS

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN.

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

INDICATIONS

For the relief of allergies due to grain and seeds.

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

*For acomplete list of Grain

and Seed Antigen contact

BioActive Nutritional, Inc.

PACKAGE LABEL DISPLAY:

BioActive Homepathic

Grain and Seed Antigens

1 FL OZ (30 ml)

GRAIN AND SEED ANTIGENS 
barley, oats, wheat, rice, rye, millet, soybean, corn, milo, bamboo, cotton seed, flax seed, safflower, sesame, sunflower, poppy seed, sorghum, sugarcane, arsenicum album, lycopodium clavatum, natrum muriaticum, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0068
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R)	BARLEY	9 [hp_X]  in 1 mL
OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK)	OAT	9 [hp_X]  in 1 mL
WHEAT (UNII: 4J2I0SN84Y) (WHEAT - UNII:4J2I0SN84Y)	WHEAT	9 [hp_X]  in 1 mL
BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG)	BROWN RICE	9 [hp_X]  in 1 mL
RYE (UNII: 0R4AQI398X) (RYE - UNII:0R4AQI398X)	RYE	9 [hp_X]  in 1 mL
MILLET (UNII: TJR6B3R47P) (MILLET - UNII:TJR6B3R47P)	MILLET	9 [hp_X]  in 1 mL
SOYBEAN (UNII: L7HT8F1ZOD) (SOYBEAN - UNII:L7HT8F1ZOD)	SOYBEAN	9 [hp_X]  in 1 mL
CORN (UNII: 0N8672707O) (CORN - UNII:0N8672707O)	CORN	9 [hp_X]  in 1 mL
SORGHUM BICOLOR WHOLE (UNII: Y3T98X3AL6) (SORGHUM BICOLOR WHOLE - UNII:Y3T98X3AL6)	SORGHUM BICOLOR WHOLE	9 [hp_X]  in 1 mL
LOPHATHERUM GRACILE LEAF (UNII: R417138GE9) (LOPHATHERUM GRACILE LEAF - UNII:R417138GE9)	LOPHATHERUM GRACILE LEAF	9 [hp_X]  in 1 mL
COTTON SEED (UNII: DI0ZRJ0MXN) (COTTON SEED - UNII:DI0ZRJ0MXN)	COTTON SEED	9 [hp_X]  in 1 mL
FLAX SEED (UNII: 4110YT348C) (FLAX SEED - UNII:4110YT348C)	FLAX SEED	9 [hp_X]  in 1 mL
SAFFLOWER (UNII: 4VBL71TY4Y) (SAFFLOWER - UNII:4VBL71TY4Y)	SAFFLOWER	9 [hp_X]  in 1 mL
SESAME SEED (UNII: 7Y1255HVXR) (SESAME SEED - UNII:7Y1255HVXR)	SESAME SEED	9 [hp_X]  in 1 mL
SUNFLOWER SEED (UNII: R9N3379M4Z) (SUNFLOWER SEED - UNII:R9N3379M4Z)	SUNFLOWER SEED	9 [hp_X]  in 1 mL
POPPY SEED (UNII: 60RO23IR87) (POPPY SEED - UNII:60RO23IR87)	POPPY SEED	9 [hp_X]  in 1 mL
SORGHUM (UNII: CUL9PN8ELJ) (SORGHUM - UNII:CUL9PN8ELJ)	SORGHUM	9 [hp_X]  in 1 mL
SUGARCANE (UNII: 81H2R5AOH3) (SUGARCANE - UNII:81H2R5AOH3)	SUGARCANE	9 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	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: 43857-0068-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/24/2013	07/22/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0068)

Revised: 5/2016

Document Id: 8c2165d7-6fa8-437d-9d02-62443f8f1e38

Set id: 7e08efc3-bceb-4ea8-84cf-883d3b7efff8

Version: 2

Effective Time: 20160525