HISTASTAT POLLEN- baptisia tinctoria, echinacea (angustifolia), adrenalinum, allium cepa, ambrosia artemisiaefolia, arsenicum album, euphrasia officinalis, histaminum hydrochloricum, natrum muriaticum, natrum sulphuricum, nux vomica, phosphorus, pulsatilla (pratensis), sabadilla, sinapis nigra, solidago virgaurea, sulphur, wyethia helenioides liquid
Energique, 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:

(in each drop): 6.24% of Adrenalinum 12X, Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Euphrasia Officinalis 12X, Histaminum Hydrochloricum 12X, Natrum Muriaticum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X, Pulsatilla 12X, Sabadilla 12X, Sinapis Nigra 12X, Solidago Virgaurea 12X, Sulphur 12X, Wyethia Helenioides 12X; 0.10% of Baptisia Tinctoria 3X, Echinacea 3X.

PURPOSE:

May temporarily relieve sinus congestion, runny nose, and sneezing.**

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

WARNINGS:

If pregnant or breast-feeding, ask a health 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:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve sinus congestion, runny nose, and sneezing.**

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

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTASTAT POLLEN

1 fl. oz. (30 ml)

HISTASTAT POLLEN

HISTASTAT POLLEN
baptisia tinctoria, echinacea (angustifolia), adrenalinum, allium cepa, ambrosia artemisiaefolia, arsenicum album, euphrasia officinalis, histaminum hydrochloricum, natrum muriaticum, natrum sulphuricum, nux vomica, phosphorus, pulsatilla (pratensis), sabadilla, sinapis nigra, solidago virgaurea, sulphur, wyethia helenioides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0674
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA WHOLE	3 [hp_X] in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	12 [hp_X] in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	12 [hp_X] in 1 mL
AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A)	AMBROSIA ARTEMISIIFOLIA WHOLE	12 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	12 [hp_X] in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI)	PULSATILLA PRATENSIS WHOLE	12 [hp_X] in 1 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	12 [hp_X] in 1 mL
BLACK MUSTARD SEED (UNII: 8LTY55LQ8D) (BLACK MUSTARD SEED - UNII:8LTY55LQ8D)	BLACK MUSTARD SEED	12 [hp_X] in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	12 [hp_X] in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 1 mL
WYETHIA HELENIOIDES ROOT (UNII: J10PD1AQ0N) (WYETHIA HELENIOIDES ROOT - UNII:J10PD1AQ0N)	WYETHIA HELENIOIDES ROOT	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:44911-0674-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/12/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/12/2023

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0674) , api manufacture(44911-0674) , label(44911-0674) , pack(44911-0674)