Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID 59f63e2b-24fa-43a0-8334-02e6729c6ac1
Route
ORAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (3 [hp_X]) Hypericum Perforatum (6 [hp_X]) Goldenseal (12 [hp_X]) Comfrey Root Arsenic Cation (3+) Activated Charcoal Causticum Carbonate Ion Sodium Sulfate Anhydrous Phosphorus Pulsatilla Pratensis Whole Silicon Dioxide
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-12-07

Description

(in each drop)  Arsenicum Album 12X 9.98%, Carbo Vegetabilis 12X 9.98%, Causticum 12X 9.98%, Hydrastis Canadensis 6X 9.98%, Kali Carbonicum 12X 9.98%, Natrum Sulphuricum 12X 9.98%, Phosphorus 12X 9.98%, Pulsatilla 12X 9.98%, Silicea 12X 9.98%, Symphytum Officinale 6X 9.98%, Echinacea 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Purpose

Arsenicum Album - sneezing,** Carbo Vegetabilis -faintness,** Causticum – tightness in chest,** Hydrastis Canadensis – sinus congestion,** Kali Carbonicum – dry cough,** Natrum Sulphuricum – loose cough,** Phosphorus – eye irritation,** Pulsatilla – runny nose,** Silicea – shortness of breath,** Symphytum Officinale - headache,** Echinacea – watery eyes,** Hypericum Perforatum – hoarseness** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Arsenicum Album - sneezing,** Carbo Vegetabilis -faintness,** Causticum – tightness in chest,** Hydrastis Canadensis – sinus congestion,** Kali Carbonicum – dry cough,** Natrum Sulphuricum – loose cough,** Phosphorus – eye irritation,** Pulsatilla – runny nose,** Silicea – shortness of breath,** Symphytum Officinale - headache,** Echinacea – watery eyes,** Hypericum Perforatum – hoarseness** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop)  Arsenicum Album 12X 9.98%, Carbo Vegetabilis 12X 9.98%, Causticum 12X 9.98%, Hydrastis Canadensis 6X 9.98%, Kali Carbonicum 12X 9.98%, Natrum Sulphuricum 12X 9.98%, Phosphorus 12X 9.98%, Pulsatilla 12X 9.98%, Silicea 12X 9.98%, Symphytum Officinale 6X 9.98%, Echinacea 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Uses:

May temporarily relieve symptoms associated with exposure to pollutants, such as cough with expectoration.**

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

Purpose:

Arsenicum Album - sneezing,** Carbo Vegetabilis -faintness,** Causticum – tightness in chest,** Hydrastis Canadensis – sinus congestion,** Kali Carbonicum – dry cough,** Natrum Sulphuricum – loose cough,** Phosphorus – eye irritation,** Pulsatilla – runny nose,** Silicea – shortness of breath,** Symphytum Officinale - headache,** Echinacea – watery eyes,** Hypericum Perforatum – hoarseness**

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

Warnings:

Stop use and ask a doctor if symptoms persist for more than 7 days.

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.

• Consult a physician for use in children under 12 years of age.

Active Ingredients:

(in each drop) Arsenicum Album 12X 9.98%, Carbo Vegetabilis 12X 9.98%, Causticum 12X 9.98%, Hydrastis Canadensis 6X 9.98%, Kali Carbonicum 12X 9.98%, Natrum Sulphuricum 12X 9.98%, Phosphorus 12X 9.98%, Pulsatilla 12X 9.98%, Silicea 12X 9.98%, Symphytum Officinale 6X 9.98%, Echinacea 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SMOGSTAT

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

Uses: (USES:)

May temporarily relieve symptoms associated with exposure to pollutants, such as cough with expectoration.**

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

Purpose: (PURPOSE:)

Arsenicum Album - sneezing,** Carbo Vegetabilis -faintness,** Causticum – tightness in chest,** Hydrastis Canadensis – sinus congestion,** Kali Carbonicum – dry cough,** Natrum Sulphuricum – loose cough,** Phosphorus – eye irritation,** Pulsatilla – runny nose,** Silicea – shortness of breath,** Symphytum Officinale - headache,** Echinacea – watery eyes,** Hypericum Perforatum – hoarseness**

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

Warnings: (WARNINGS:)

Stop use and ask a doctor if symptoms persist for more than 7 days.

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.

• Consult a physician for use in children under 12 years of age.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) Arsenicum Album 12X 9.98%, Carbo Vegetabilis 12X 9.98%, Causticum 12X 9.98%, Hydrastis Canadensis 6X 9.98%, Kali Carbonicum 12X 9.98%, Natrum Sulphuricum 12X 9.98%, Phosphorus 12X 9.98%, Pulsatilla 12X 9.98%, Silicea 12X 9.98%, Symphytum Officinale 6X 9.98%, Echinacea 3X 0.10%, Hypericum Perforatum 3X 0.10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SMOGSTAT

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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