sleep aid™

sleep aid™
SPL v2
SPL
SPL Set ID 9b0f3ed6-c6b1-4f5d-87b0-03c8dc24039c
Route
oral
Published
Effective Date 2018-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aconitum napellus (59 [hp_X]) aesculus hippocastanum flower arsenic cation (3+) avena sativa flowering top atropa belladonna camphor (natural) cinchona officinalis bark arabica coffee bean cypripedium parvifolum root hyoscyamus niger strychnos ignatii seed passiflora incarnata flowering top pulsatilla vulgaris valerian
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 2018-04-24

Description

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.


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.
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 and 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.

Dosage and 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.
Description

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.

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

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

Section 51945-4

Section 55105-1

Uses ​for relief of symptoms due to occasional sleeplessness:

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

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.
Active Ingredient (55106-9)

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 and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses ​for relief of symptoms due to occasional sleeplessness:

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