Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID ea11c312-b26c-45c7-b2fb-14edbedd6932
Route
ORAL
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cinnamon (12 [hp_X]) Echinacea Angustifolia Goldenseal Arctium Lappa Root Trifolium Pratense Flower Viscum Album Fruiting Top
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-09-24

Description

(in each drop) Cinnamomum 12X, 30X, 200X 5.55%, Echinacea 12X, 30X, 200X 5.55%, Hydrastis Canadensis 12X, 30X, 200X 5.55%, Lappa Major 12X, 30X, 200X 5.55%, Trifolium Pratense 12X, 30X, 200X 5.55%, Viscum Album 12X, 30X, 200X 5.55%.

Purpose

Cinnamomum - pain,** Echinacea - fatigue,** Hydrastis Canadensis – mucus discharge,** Lappa Major - numbness,** Trifolium Pratense - swelling,** Viscum Album – sadness** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Cinnamomum - pain,** Echinacea - fatigue,** Hydrastis Canadensis – mucus discharge,** Lappa Major - numbness,** Trifolium Pratense - swelling,** Viscum Album – sadness** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) Cinnamomum 12X, 30X, 200X 5.55%, Echinacea 12X, 30X, 200X 5.55%, Hydrastis Canadensis 12X, 30X, 200X 5.55%, Lappa Major 12X, 30X, 200X 5.55%, Trifolium Pratense 12X, 30X, 200X 5.55%, Viscum Album 12X, 30X, 200X 5.55%.

Uses:

May temporarily relieve: •sore throat •extreme fatigue •glandular swelling •mucous discharge.**

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

Purpose:

Cinnamomum - pain,** Echinacea - fatigue,** Hydrastis Canadensis – mucus discharge,** Lappa Major - numbness,** Trifolium Pratense - swelling,** Viscum Album – sadness**

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

Warnings:

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Stop use and ask a doctor if symptoms persist for more than 2 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) Cinnamomum 12X, 30X, 200X 5.55%, Echinacea 12X, 30X, 200X 5.55%, Hydrastis Canadensis 12X, 30X, 200X 5.55%, Lappa Major 12X, 30X, 200X 5.55%, Trifolium Pratense 12X, 30X, 200X 5.55%, Viscum Album 12X, 30X, 200X 5.55%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

REGEN HP

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: •sore throat •extreme fatigue •glandular swelling •mucous discharge.**

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

Purpose: (PURPOSE:)

Cinnamomum - pain,** Echinacea - fatigue,** Hydrastis Canadensis – mucus discharge,** Lappa Major - numbness,** Trifolium Pratense - swelling,** Viscum Album – sadness**

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

Warnings: (WARNINGS:)

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.

Stop use and ask a doctor if symptoms persist for more than 2 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) Cinnamomum 12X, 30X, 200X 5.55%, Echinacea 12X, 30X, 200X 5.55%, Hydrastis Canadensis 12X, 30X, 200X 5.55%, Lappa Major 12X, 30X, 200X 5.55%, Trifolium Pratense 12X, 30X, 200X 5.55%, Viscum Album 12X, 30X, 200X 5.55%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

REGEN HP

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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