Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 00478787-ccec-4101-a0da-fd337037c3ee
Route
ORAL
Published
Effective Date 2023-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baptisia Tinctoria Root (3 [hp_X]) Echinacea Angustifolia (12 [hp_X]) Epinephrine Onion Ambrosia Artemisiifolia Arsenic Cation (3+) Euphrasia Stricta Histamine Chloride Ion Sodium Sulfate Anhydrous Strychnos Nux-vomica Seed Phosphorus Pulsatilla Pratensis Whole Schoenocaulon Officinale Seed Black Mustard Seed Solidago Virgaurea Flowering Top Sulfur Wyethia Helenioides Root
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-05-12

Description

(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.


Medication Information

Purpose

May temporarily relieve sinus congestion, runny nose, and sneezing.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

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.

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.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTASTAT POLLEN

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

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

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

Warnings: (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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

Directions: (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: (INDICATIONS:)

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

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

Active Ingredients: (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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTASTAT POLLEN

1 fl. oz. (30 ml)

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.


Advanced Ingredient Data


Raw Label Data

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