SLEEP AID- aconitum nap, aesculus hipp, flos, arsenicum alb, avena, belladonna, camphora, cinchona, coffea cruda, cypripedium, hyoscyamus, ignatia, passiflora, pulsatilla, valeriana. liquid

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Aconitum nap, Aesculus hipp, flos, Arsenicum alb, Avena, Belladonna, Camphora, Cinchona, Coffea cruda, Cypripedium, Hyoscyamus, Ignatia, Passiflora, Pulsatilla, Valerian.

Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

INDICATIONS & USAGE

Uses for relief of symptoms due to occasional sleeplessness: inability to fall or stay asleep, restless tossing, fear and worry, light sleeping, and overactive mind.

INACTIVE INGREDIENT

Inactive Ingredients: Bio-Energetically Enhanced™ pure water, Carya ovaa bark exract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

WARNINGS

Warnings

• Stop use and ask your doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, take only on advice of a healthcare professional.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• Initially, depress pump until primed.
• Spray one dose directly into mouth.
• Adults 12 and up: 3 sprays 3 times per day.
• Children 2-12: 2 sprays 3 times per day.
• Children 2 mo.-2yr: 1 spray 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

PURPOSE

Uses ​for relief of symptoms due to occasional sleeplessness:

• inability to fall or stay asleep
• restless tossing
• fear and worry
• light sleeping
• overactive mind

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SLEEP AID 
aconitum nap, aesculus hipp, flos, arsenicum alb, avena, belladonna, camphora, cinchona, coffea cruda, cypripedium, hyoscyamus, ignatia, passiflora, pulsatilla, valeriana. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-2641
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	59 [hp_X]  in 59 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	59 [hp_X]  in 59 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	59 [hp_X]  in 59 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	59 [hp_X]  in 59 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	59 [hp_X]  in 59 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	59 [hp_X]  in 59 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	59 [hp_X]  in 59 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	59 [hp_X]  in 59 mL
CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFOLUM ROOT	59 [hp_X]  in 59 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	59 [hp_X]  in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	59 [hp_X]  in 59 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	59 [hp_X]  in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	59 [hp_X]  in 59 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	59 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARYA OVATA BARK (UNII: X765CF609L)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-2641-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/24/2018

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(57955-2641)