Spaced Out™

Spaced Out™
SPL v4
SPL
SPL Set ID 27b68f42-63ee-486f-8779-4eb6ad62031c
Route
ORAL
Published
Effective Date 2018-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Asarum Europaeum (10 [hp_X]) 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 Sulfur
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 2018-03-14

Description

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.


Medication Information

Warnings and Precautions

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.
Indications and Usage

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

Dosage and Administration

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.
Description

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.

Section 50565-1
  • Keep out of reach of children
Section 51727-6

Inactive Ingredients:

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

Section 51945-4

Section 55105-1

Uses for temporary relief of symptoms:

  • daydreaming
  • reminiscent
  • absent-mindedness
  • unobservant
  • lack of focus
  • easily distracted
  • spaced out
Section 55106-9

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.

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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.
Section 50565-1 (50565-1)
  • Keep out of reach of children
Section 51727-6 (51727-6)

Inactive Ingredients:

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses for temporary relief of symptoms:

  • daydreaming
  • reminiscent
  • absent-mindedness
  • unobservant
  • lack of focus
  • easily distracted
  • spaced out
Section 55106-9 (55106-9)

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.

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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