Sleep Aid: Homeopathic Product Information

SLEEP AID- aconitum napellus whole, aesculus hippocastanum flower, arsenic trioxide, avena sativa flowering top, atropa belladonna, camphor (natural), cinchona officinalis bark, arabica coffee bean, cypripedium parviflorum var. pubescens root, hyoscyamus niger, dibasic potassium phosphate, strychnos ignatii seed, passiflora incarnata flowering top, phosphorus, pulsatilla vulgaris whole and valerian liquid
King Bio Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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.

Reference image:Sleep .jpg

Other information

Tamper resistant for your protection.

Use only if safety seal is intact.

Keep carton for complete drug facts and product information.

Questions? Call 866.298.2740

King Bio, Inc. 3 Westside Drive

Asheville, NC 2806 USA

FDA Reg. #1053442

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

Reference image:Sleep .jpg

Inactive Ingredients

Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

Reference image:Sleep .jpg

Active ingredients

Equal volumes of each HPUS** 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, Kali phosphoricum, Ignatia amara, Passiflora incarnata, Phosphorus,
Pulsatilla, Valeriana officinalis.

HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Reference image:Sleep .jpg

Uses

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.

Reference image:Sleep .jpg

Warnings

Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.

If pregnant or breast-feeding , ask a healthcare professional
before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Sleep .jpg

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Reference image:Sleep .jpg

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
Kali phosphoricum……………………………………………night terrors
Ignatia amara …………………………………………..light sleep, worry
Passiflora incarnata…………………………..restlessness, wakefulness
Phosphorus …………………………………………………..sleeplessness
Pulsatilla ………………………………………….irregular sleep patterns
Valeriana officinalis……………………………………tossing and turning


**“HPUS” indicates the active ingredients are in the officialHomeopathic Pharmacopeia of the United States.

Reference image:Sleep .jpg

image description
(click image for full-size original)

SLEEP AID aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, kali phosphoricum, ignatia amara, passiflora incarnata, phosphorus, pulsatilla, valeriana officinalis. liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-5638
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS WHOLE (ACONITUM NAPELLUS) ACONITUM NAPELLUS WHOLE 10 [hp_X] in 59 mL
AESCULUS HIPPOCASTANUM FLOWER (AESCULUS HIPPOCASTANUM FLOWER) AESCULUS HIPPOCASTANUM FLOWER 10 [hp_X] in 59 mL
ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 10 [hp_X] in 59 mL
AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 10 [hp_X] in 59 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 10 [hp_X] in 59 mL
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 10 [hp_X] in 59 mL
CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 10 [hp_X] in 59 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 10 [hp_X] in 59 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 10 [hp_X] in 59 mL
HYOSCYAMUS NIGER (HYOSCYAMUS NIGER) HYOSCYAMUS NIGER 10 [hp_X] in 59 mL
DIBASIC POTASSIUM PHOSPHATE (PHOSPHATE ION) DIBASIC POTASSIUM PHOSPHATE 10 [hp_X] in 59 mL
STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 10 [hp_X] in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 10 [hp_X] in 59 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 10 [hp_X] in 59 mL
PULSATILLA VULGARIS WHOLE (ANEMONE PULSATILLA) PULSATILLA VULGARIS WHOLE 10 [hp_X] in 59 mL
VALERIAN (VALERIAN) VALERIAN 10 [hp_X] in 59 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
CITRUS AURANTIUM FRUIT OIL
ORANGE PEEL
CITRUS RETICULATA FRUIT OIL
WATER
GLYCERIN
LACTIC ACID, UNSPECIFIED FORM
LONICERA JAPONICA FLOWER
BENZYLPENICILLOYL POLYLYSINE
CARYA OVATA BARK
STEVIOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57955-5638-2 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 59 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (57955-5638-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 08/16/2022
Labeler — King Bio Inc. (617901350)
Registrant — King Bio Inc. (617901350)
Establishment
Name Address ID/FEI Operations
King Bio Inc. 617901350 manufacture (57955-5638), api manufacture (57955-5638)

Revised: 12/2022 King Bio Inc.

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