Sleep Aid

Sleep Aid
SPL v3
SPL
SPL Set ID 57503fe4-0c7c-4d38-bccb-c9bda9bf1e41
Route
ORAL
Published
Effective Date 2020-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Aesculus Hippocastanum Flower Arsenic Cation (3+) Avena Sativa Flowering Top Atropa Belladonna Camphor (natural) Cinchona Officinalis Bark Arabica Coffee Bean Cypripedium Parviflorum Var. Pubescens Root Hyoscyamus Niger Strychnos Ignatii Seed Passiflora Incarnata Flower Pulsatilla Vulgaris Valerian
Inactive Ingredients
Water Carya Ovata Bark Citrus Bioflavonoids Lonicera Japonica Flower Polyepsilon-lysine (4000 Mw) Rebaudioside A

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-02-01

Description

HPUS active ingredients Equal volumes of each ingredient in 10X, 30X, and 1LM potencies Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

Purpose

HPUS active ingredients                   Purpose Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM potencies. Aconitum napellus...................................fear, worry Aesculus hippocastanum, flos....................heavy eyelids Arsenicum album....................................anguish, fears Avena sativa..........................................nervous exhaustion Belladonna.............................................restlessness Camphora.............................................restless tossing Cinchona officinalis.................................anxious dreams, early waking Coffea cruda.........................................nervous excitability Cypripedium pubescens.........................wakefulness Hyoscyamus niger.................................inability to fall asleep Ignatia amara.........................................light sleep, worry Passiflora incarnata................................restlessness, wakefulness Pulsatilla................................................irregular sleep patterns Valeriana officinalis................................tossing and turning **“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.


Medication Information

Indications and Usage

Uses for temporary relief of symptoms due to occasional

sleeplessness: █ restlessness █ nervousness █ exhaustion

█ excitability █ inability to fall or stay asleep █ worry.

† as per various homeopathic materia medicas. Claims based

on traditional homeopathic practice, not accepted medical

evidence. These uses have not been evaluated by the FDA,

and product has not been clinically tested.

Purpose

HPUS active ingredients                   Purpose

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM

potencies.

Aconitum napellus...................................fear, worry

Aesculus hippocastanum, flos....................heavy eyelids

Arsenicum album....................................anguish, fears

Avena sativa..........................................nervous exhaustion

Belladonna.............................................restlessness

Camphora.............................................restless tossing

Cinchona officinalis.................................anxious dreams, early waking

Coffea cruda.........................................nervous excitability

Cypripedium pubescens.........................wakefulness

Hyoscyamus niger.................................inability to fall asleep

Ignatia amara.........................................light sleep, worry

Passiflora incarnata................................restlessness, wakefulness

Pulsatilla................................................irregular sleep patterns

Valeriana officinalis................................tossing and turning

**“HPUS” indicates the active ingredients are in the official

Homeopathic Pharmacopeia of the United States.

Description

HPUS active ingredients Equal volumes of each ingredient in 10X, 30X, and 1LM potencies Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

Section 50565-1

█ Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center immediately.

Section 51945-4

Section 53413-1

Questions? Call 866.298.2740

King Bio, Inc. • 3 Westside Drive

Asheville, NC 28806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Section 53414-9

█ If pregnant or breast-feeding, ask a healthcare professional

before use.

Warnings

█ Stop use and consult a physician if symptoms worsen or

persist for more than 7 days.



Directions

█ Initially, depress pump until

primed.

█ Spray one dose directly into

mouth.

█ Adults: 3 sprays 3 times per

day.

█ Children ages 6-12: 2 sprays 3

times per day.

█ Consult a physician for use in

children under 6 years of age.

█ Use additionally as needed, up

to 6 times per day.

Active Ingredients

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and 1LM potencies

Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

Inactive Ingredients

Bio-Energetically Enhanced™ pure

water, citrus extract* (ascorbic

acid, citric acid, citrus aurantium

amara fruit extract, citrus

aurantium sinensis peel extract,

citrus reticulata fruit extract,

demineralized water, glycerin,

lactic acid), Honeysuckle (Lonicera

japonica), polylysine, Shagbark

Hickory (Carya ovata) Bark

Extract, steviol (Steviol

glycosides).

other Information

Tamper resistant for your protection. Use only if safety seal is intact.


Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of symptoms due to occasional

sleeplessness: █ restlessness █ nervousness █ exhaustion

█ excitability █ inability to fall or stay asleep █ worry.

† as per various homeopathic materia medicas. Claims based

on traditional homeopathic practice, not accepted medical

evidence. These uses have not been evaluated by the FDA,

and product has not been clinically tested.

Section 50565-1 (50565-1)

█ Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center immediately.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 866.298.2740

King Bio, Inc. • 3 Westside Drive

Asheville, NC 28806 USA

FDA Reg. #1053442

For latest product information and instructions: www.DrKings.com

Section 53414-9 (53414-9)

█ If pregnant or breast-feeding, ask a healthcare professional

before use.

Purpose

HPUS active ingredients                   Purpose

Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM

potencies.

Aconitum napellus...................................fear, worry

Aesculus hippocastanum, flos....................heavy eyelids

Arsenicum album....................................anguish, fears

Avena sativa..........................................nervous exhaustion

Belladonna.............................................restlessness

Camphora.............................................restless tossing

Cinchona officinalis.................................anxious dreams, early waking

Coffea cruda.........................................nervous excitability

Cypripedium pubescens.........................wakefulness

Hyoscyamus niger.................................inability to fall asleep

Ignatia amara.........................................light sleep, worry

Passiflora incarnata................................restlessness, wakefulness

Pulsatilla................................................irregular sleep patterns

Valeriana officinalis................................tossing and turning

**“HPUS” indicates the active ingredients are in the official

Homeopathic Pharmacopeia of the United States.

Warnings

█ Stop use and consult a physician if symptoms worsen or

persist for more than 7 days.



Directions

█ Initially, depress pump until

primed.

█ Spray one dose directly into

mouth.

█ Adults: 3 sprays 3 times per

day.

█ Children ages 6-12: 2 sprays 3

times per day.

█ Consult a physician for use in

children under 6 years of age.

█ Use additionally as needed, up

to 6 times per day.

Active Ingredients

HPUS active ingredients

Equal volumes of each ingredient in 10X, 30X, and 1LM potencies

Aconitum napellus, Aesculus hippocastanum, flos, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

Inactive Ingredients

Bio-Energetically Enhanced™ pure

water, citrus extract* (ascorbic

acid, citric acid, citrus aurantium

amara fruit extract, citrus

aurantium sinensis peel extract,

citrus reticulata fruit extract,

demineralized water, glycerin,

lactic acid), Honeysuckle (Lonicera

japonica), polylysine, Shagbark

Hickory (Carya ovata) Bark

Extract, steviol (Steviol

glycosides).

other Information (Other Information)

Tamper resistant for your protection. Use only if safety seal is intact.


Advanced Ingredient Data


Raw Label Data

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