Sleep Aid
Sleep Aid
44daeef5-1e4d-474e-ae60-1131c15e470e
HUMAN OTC DRUG LABEL
May 19, 2025
King Bio Inc.
DUNS: 617901350
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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.
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (28)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
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
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INACTIVE INGREDIENT SECTION
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
OTC - ACTIVE INGREDIENT SECTION
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
WARNINGS SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
Reference image:Sleep .jpg
OTC - PURPOSE SECTION
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 official
Homeopathic Pharmacopeia of the United States.
Reference image:Sleep .jpg