Sprayology Sleepease

Sprayology Sleepease
SPL v1
SPL
SPL Set ID 5e67c4d8-fca8-4450-817a-009841c8c163
Route
ORAL
Published
Effective Date 2016-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aquilegia Vulgaris (2 [hp_X]) Avena Sativa Flowering Top (200 [hp_C]) Matricaria Recutita (3 [hp_X]) Arabica Coffee Bean (12 [hp_X]) Cypripedium Parvifolum Root Hops Phosphate Ion Passiflora Incarnata Flowering Top Valerian Zinc
Inactive Ingredients
Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-07-28

Description

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.


Medication Information

Warnings and Precautions

Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

Temporarily relieves the common symptoms of sleeplessness, including:

  • wakefulness
  • restlessness
  • emotional stress and anxiety
  • caffeine sensitivity
Dosage and Administration

Directions:

  • Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.
  • Ages 2 to 12: 1 spray into the mouth at bedtime and if sleep is interrupted.
  • Under age 2: consult a health care professional.
Description

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v and purified water.

Section 51945-4

Section 55105-1

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

Section 55106-9

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.

Section 60561-8

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves the common symptoms of sleeplessness, including:

  • wakefulness
  • restlessness
  • emotional stress and anxiety
  • caffeine sensitivity
Dosage and Administration (34068-7)

Directions:

  • Adults and children over 12: 2 sprays into the mouth at bedtime and if sleep is interrupted.
  • Ages 2 to 12: 1 spray into the mouth at bedtime and if sleep is interrupted.
  • Under age 2: consult a health care professional.
Warnings and Precautions (34071-1)

Warnings: If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v and purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporarily relieves the common symptoms of sleeplessness, including:

° wakefulness

° restlessness

° emotional stress and anxiety

° caffeine sensitivity

° natural

° gluten free

° no artifical flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

Section 55106-9 (55106-9)

Active Ingredient: Aquilegia vulgaris 2X, Avena sativa 2X, Chamomilla 2X, Coffea cruda 200C, Cypripedium pubescens 3X, Humulus lupulus 3X, Kali phosphoricum 12X, Passiflora incarnata 2X, Valeriana officinalis 2X, Zincum metallicum 12X.

Section 60561-8 (60561-8)

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.


Advanced Ingredient Data


Raw Label Data

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