Spaced Out: Homeopathic Product Information

SPACED OUT- asarum europaeum, clematis recta flowering top, clematis vitalba flower, anamirta cocculus seed, lathyrus sativas seed, lonicera caprifolium flowering top, achillea millefolium, naja naja venom, nutmeg, nerium oleander leaf, rosa damascena flowering top, rosmarinus officinalis flowering top, corn silk and sulfur 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.

Drug Facts ​__________________________________________________________________________________________________________

HPUS active ingredients: Asarum europaeum, Clematis erecta, Clematis vitalba, flos, Cocculus indicus, Lathyrus sativus, Lonicera caprifolium, flos, Millefolium, Naja tripudians, Nux moschata, Oleander, Rosa damascena, Rosmarinus officinalis, Stigmata maidis, Sulphur. Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

Uses for temporary relief of symptoms: daydreaming, reminiscent, absent-mindedness, unobservant, lack of focus, easily distracted, spaced out.

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

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

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day
  • Use additionally as needed, up to 6 times per day.

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

Uses for temporary relief of symptoms:

  • daydreaming
  • reminiscent
  • absent-mindedness
  • unobservant
  • lack of focus
  • easily distracted
  • spaced out

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SPACED OUT
asarum europaeum, clematis erecta, clematis vitalba, flos, cocculus indicus, lathyrus sativus, lonicera caprifolium, flos, millefolium, naja tripudians, nux moschata, oleander, rosa damascena, rosmarinus officinalis, stigmata maidis, sulphur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-1541
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASARUM EUROPAEUM (ASARUM EUROPAEUM) ASARUM EUROPAEUM 10 [hp_X] in 59 mL
CLEMATIS RECTA FLOWERING TOP (CLEMATIS RECTA FLOWERING TOP) CLEMATIS RECTA FLOWERING TOP 10 [hp_X] in 59 mL
CLEMATIS VITALBA FLOWER (CLEMATIS VITALBA FLOWER) CLEMATIS VITALBA FLOWER 10 [hp_X] in 59 mL
ANAMIRTA COCCULUS SEED (ANAMIRTA COCCULUS SEED) ANAMIRTA COCCULUS SEED 10 [hp_X] in 59 mL
LATHYRUS SATIVAS SEED (LATHYRUS SATIVAS SEED) LATHYRUS SATIVAS SEED 10 [hp_X] in 59 mL
LONICERA CAPRIFOLIUM FLOWERING TOP (LONICERA CAPRIFOLIUM FLOWERING TOP) LONICERA CAPRIFOLIUM FLOWERING TOP 10 [hp_X] in 59 mL
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 10 [hp_X] in 59 mL
NAJA NAJA VENOM (NAJA NAJA VENOM) NAJA NAJA VENOM 10 [hp_X] in 59 mL
NUTMEG (NUTMEG) NUTMEG 10 [hp_X] in 59 mL
NERIUM OLEANDER LEAF (NERIUM OLEANDER LEAF) NERIUM OLEANDER LEAF 10 [hp_X] in 59 mL
ROSA DAMASCENA FLOWERING TOP (ROSA DAMASCENA FLOWERING TOP) ROSA DAMASCENA FLOWERING TOP 10 [hp_X] in 59 mL
ROSMARINUS OFFICINALIS FLOWERING TOP (ROSMARINUS OFFICINALIS FLOWERING TOP) ROSMARINUS OFFICINALIS FLOWERING TOP 10 [hp_X] in 59 mL
CORN SILK (CORN SILK) CORN SILK 10 [hp_X] in 59 mL
SULFUR (SULFUR) SULFUR 10 [hp_X] in 59 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARYA OVATA BARK
CITRUS BIOFLAVONOIDS
LONICERA JAPONICA FLOWER
POLYEPSILON-LYSINE (4000 MW)
REBAUDIOSIDE A
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57955-1541-2 59 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/14/2018
Labeler — King Bio Inc. (617901350)
Registrant — King Bio Inc. (617901350)
Establishment
Name Address ID/FEI Operations
King Bio Inc. 617901350 manufacture (57955-1541)

Revised: 03/2018 King Bio Inc.

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