Sleepease

Sleepease
SPL v6
SPL
SPL Set ID 9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6
Route
ORAL
Published
Effective Date 2023-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aquilegia Vulgaris (4 [hp_X]) Avena Sativa Flowering Top (200 [hp_C]) Matricaria Chamomilla Whole (12 [hp_X]) Arabica Coffee Bean Cypripedium Parviflorum Var. Pubescens Root Hops Phosphate Ion Passiflora Incarnata Flowering Top Valerian Zinc
Inactive Ingredients
Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-04-24

Description

Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

Purpose

Temporarily relieves the common symptoms of sleeplessness, including: ° wakefulness ° restlessness ° emotional stress and anxiety ° caffeine sensitivity ° natural ° gluten free ° no artifical flavors or colors ° vegan ° no known negative side effects ° no known negative drug interactions


Medication Information

Purpose

Temporarily relieves the common symptoms of sleeplessness, including: ° wakefulness ° restlessness ° emotional stress and anxiety ° caffeine sensitivity ° natural ° gluten free ° no artifical flavors or colors ° vegan ° no known negative side effects ° no known negative drug interactions

Description

Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

Purpose:

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

Warnings:

If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.Children Under 12: consult a health care professional.

Indications:

Temporarily relieves the common symptoms of sleeplessness, including:

º wakefulness

º restlessness

º emotional stress and anxiety

º caffeine sensitivity

Other Information:

Do not use if the transparent seal around spray bottle is broken or missing.

Active Ingredients:

Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

Inactive Ingredients:

Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

Package Label Display:

NDC 61096-2001-1

sprayology

SleepEase

RELIEVES 

RESTLESSNESS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

Warnings: (WARNINGS:)

If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Directions: (DIRECTIONS:)

Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.Children Under 12: consult a health care professional.

Indications: (INDICATIONS:)

Temporarily relieves the common symptoms of sleeplessness, including:

º wakefulness

º restlessness

º emotional stress and anxiety

º caffeine sensitivity

Other Information: (OTHER INFORMATION:)

Do not use if the transparent seal around spray bottle is broken or missing.

Active Ingredients: (ACTIVE INGREDIENTS:)

Aquilegia 4X, Avena 4X, Chamomilla 4X, Coffea cruda 200C, Cypripedium 4X, Humulus 4X, Kali phos 12X, Passiflora 4X, Valeriana 4X, Zinc met 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Non-GMO Glycerin, organic alcohol 20% v/v, purified water.

Package Label Display: (PACKAGE LABEL DISPLAY:)

NDC 61096-2001-1

sprayology

SleepEase

RELIEVES 

RESTLESSNESS

HOMEOPATHIC ORAL SPRAY

1.38 fl.oz (41 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Contains alcohol, 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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