Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID be8d4987-229f-49e5-9027-62c523934b4d
Route
ORAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Clematis Vitalba Flower (30 [hp_C]) Helianthemum Nummularium Flower Impatiens Glandulifera Flower Ornithogalum Umbellatum Flowering Top Prunus Cerasifera Flower
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-07-30

Description

(in each drop)  Clematis Vitalba, Flos 30C, 200C 10%, Helianthemum Nummularium, Flos 30C, 200C 10%, Impatiens Glandulifera, Flos 30C, 200C 10%, Ornithogalum Umbellatum, Flos 30C, 200C 10%, Prunus Cerasifera, Flos 30C, 200C 10%.

Purpose

Clematis Vitalba, Flos – sadness,** Helianthemum Nummularium, Flos - fear,** Impatiens Glandulifera, Flos - loneliness,** Ornithogalum Umbellatum, Flos – emotional shock,** Prunus Cerasifera, Flos – stress** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

Clematis Vitalba, Flos – sadness,** Helianthemum Nummularium, Flos - fear,** Impatiens Glandulifera, Flos - loneliness,** Ornithogalum Umbellatum, Flos – emotional shock,** Prunus Cerasifera, Flos – stress** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop)  Clematis Vitalba, Flos 30C, 200C 10%, Helianthemum Nummularium, Flos 30C, 200C 10%, Impatiens Glandulifera, Flos 30C, 200C 10%, Ornithogalum Umbellatum, Flos 30C, 200C 10%, Prunus Cerasifera, Flos 30C, 200C 10%.

Uses:

May temporarily relieve: •trauma •terror •panic •tension •fear effects of startling experiences.**

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

Purpose:

Clematis Vitalba, Flos – sadness,** Helianthemum Nummularium, Flos - fear,** Impatiens Glandulifera, Flos - loneliness,** Ornithogalum Umbellatum, Flos – emotional shock,** Prunus Cerasifera, Flos – stress**

**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, 1 time 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) Clematis Vitalba, Flos 30C, 200C 10%, Helianthemum Nummularium, Flos 30C, 200C 10%, Impatiens Glandulifera, Flos 30C, 200C 10%, Ornithogalum Umbellatum, Flos 30C, 200C 10%, Prunus Cerasifera, Flos 30C, 200C 10%.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

RESCUE 5

30C, 200C

2 fl. oz. (60 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: •trauma •terror •panic •tension •fear effects of startling experiences.**

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

Purpose: (PURPOSE:)

Clematis Vitalba, Flos – sadness,** Helianthemum Nummularium, Flos - fear,** Impatiens Glandulifera, Flos - loneliness,** Ornithogalum Umbellatum, Flos – emotional shock,** Prunus Cerasifera, Flos – stress**

**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, 1 time 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) Clematis Vitalba, Flos 30C, 200C 10%, Helianthemum Nummularium, Flos 30C, 200C 10%, Impatiens Glandulifera, Flos 30C, 200C 10%, Ornithogalum Umbellatum, Flos 30C, 200C 10%, Prunus Cerasifera, Flos 30C, 200C 10%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

RESCUE 5

30C, 200C

2 fl. oz. (60 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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