Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID eb3bc662-3d3d-4e4d-8561-330ad0eb08f2
Route
ORAL
Published
Effective Date 2023-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (3 [hp_X]) Hops (6 [hp_X]) Passiflora Incarnata Flowering Top (6 [hp_C]) Phosphate Ion Phosphoric Acid Semecarpus Anacardium Juice Silver Cation Strychnos Ignatii Seed
Inactive Ingredients
Water Alcohol Glycerin Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-03-23

Description

(in each drop) Avena Sativa 3X 12.50%, Humulus Lupulus 3X 12.50%, Passiflora Incarnata 3X 12.50%, Kali Phosphoricum 6X 12.50%, Phosphoricum Acidum 6X 12.50%, Anacardium Orientale 6C 12.50%, Argentum Nitricum 6C 12.50%, Ignatia Amara 6C 12.50%.

Purpose

Avena Sativa – nervousness, sleeplessness,* Humulus Lupulus – overexcitement, tension,* Passiflora Incarnata – worries, insomnia,* Kali Phosphoricum – overwork, fatigue,* Phosphoricum Acidum – mental exhaustion,* Anacardium Orientale – doubt, apprehension, * Argentum Nitricum – fear, anxiousness,* Ignatia Amara – hypersensitivity, grief.*


Medication Information

Purpose

Avena Sativa – nervousness, sleeplessness,* Humulus Lupulus – overexcitement, tension,* Passiflora Incarnata – worries, insomnia,* Kali Phosphoricum – overwork, fatigue,* Phosphoricum Acidum – mental exhaustion,* Anacardium Orientale – doubt, apprehension, * Argentum Nitricum – fear, anxiousness,* Ignatia Amara – hypersensitivity, grief.*

Description

(in each drop) Avena Sativa 3X 12.50%, Humulus Lupulus 3X 12.50%, Passiflora Incarnata 3X 12.50%, Kali Phosphoricum 6X 12.50%, Phosphoricum Acidum 6X 12.50%, Anacardium Orientale 6C 12.50%, Argentum Nitricum 6C 12.50%, Ignatia Amara 6C 12.50%.

Uses:

May temporarily relieve anxiousness, stress, and physical exhaustion and help you sleep.*

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

Purpose:

Avena Sativa – nervousness, sleeplessness,* Humulus Lupulus – overexcitement, tension,* Passiflora Incarnata – worries, insomnia,* Kali Phosphoricum – overwork, fatigue,* Phosphoricum Acidum – mental exhaustion,* Anacardium Orientale – doubt, apprehension, * Argentum Nitricum – fear, anxiousness,* Ignatia Amara – hypersensitivity, grief.*

Warnings:

For oral use only.

If pregnant or breast-feeding, ask a health care 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

Questions:

Dist. by Ratis, LLC:

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

www.HomeopathyStore.com

(888) 405-7551

Directions:

• Adults: 2 sprays 3 times a day or as needed.

• Children under 12: 1 spray as above

• Consult a physician for use in children under 6 years of age.

Store in a cool, dry place.

Active Ingredient:

(in each drop) Avena Sativa 3X 12.50%, Humulus Lupulus 3X 12.50%, Passiflora Incarnata 3X 12.50%, Kali Phosphoricum 6X 12.50%, Phosphoricum Acidum 6X 12.50%, Anacardium Orientale 6C 12.50%, Argentum Nitricum 6C 12.50%, Ignatia Amara 6C 12.50%.

Inactive Ingredients:

Citric acid, demineralized water, organic ethanol 1.6%, glycerin

Package Label Display:

LACTOSE FREE

ANNA

KARE

Peacefuli

ANXIETY & STRESS RELIEF *

HOMEOPATHIC ORAL SPRAY

1 FL. OZ (30ML)

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 anxiousness, stress, and physical exhaustion and help you sleep.*

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

Purpose: (PURPOSE:)

Avena Sativa – nervousness, sleeplessness,* Humulus Lupulus – overexcitement, tension,* Passiflora Incarnata – worries, insomnia,* Kali Phosphoricum – overwork, fatigue,* Phosphoricum Acidum – mental exhaustion,* Anacardium Orientale – doubt, apprehension, * Argentum Nitricum – fear, anxiousness,* Ignatia Amara – hypersensitivity, grief.*

Warnings: (WARNINGS:)

For oral use only.

If pregnant or breast-feeding, ask a health care 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

Questions: (QUESTIONS:)

Dist. by Ratis, LLC:

1201 N Orange St,

Ste 7594

Wilmington, DE 19801

www.HomeopathyStore.com

(888) 405-7551

Directions: (DIRECTIONS:)

• Adults: 2 sprays 3 times a day or as needed.

• Children under 12: 1 spray as above

• Consult a physician for use in children under 6 years of age.

Store in a cool, dry place.

Active Ingredient: (ACTIVE INGREDIENT:)

(in each drop) Avena Sativa 3X 12.50%, Humulus Lupulus 3X 12.50%, Passiflora Incarnata 3X 12.50%, Kali Phosphoricum 6X 12.50%, Phosphoricum Acidum 6X 12.50%, Anacardium Orientale 6C 12.50%, Argentum Nitricum 6C 12.50%, Ignatia Amara 6C 12.50%.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Citric acid, demineralized water, organic ethanol 1.6%, glycerin

Package Label Display: (PACKAGE LABEL DISPLAY:)

LACTOSE FREE

ANNA

KARE

Peacefuli

ANXIETY & STRESS RELIEF *

HOMEOPATHIC ORAL SPRAY

1 FL. OZ (30ML)

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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