Sprayology Stress Relief

Sprayology Stress Relief
SPL v1
SPL
SPL Set ID 062905de-9e33-4003-8168-346de85e860b
Route
ORAL
Published
Effective Date 2014-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chaste Tree (6 [hp_X]) Avena Sativa Flowering Top (1 [hp_X]) Cinchona Officinalis Bark (2 [hp_X]) Hops (200 [hp_C]) Hyoscyamus Niger (3 [hp_X]) Strychnos Ignatii Seed Passiflora Incarnata Flowering Top Valerian
Inactive Ingredients
Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-02-26

Description

Active Ingredients: Agnus castus 6X, Avena sativa 1X, Cinchona officinalis 6X, Humulus lupulus 2X, Hyoscyamus niger 200C, Ignatia amara 200C, Passiflora incarnata 3X, Valeriana officinalis 3X


Medication Information

Warnings and Precautions

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. 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 feelings of stress, including:

° anxiety

° nervousness

° mood swings

° irritability

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

Dosage and Administration

Directions:

  • Adults and children over 12: 2 sprays into the mouth each 60 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
  • Ages 2 to 12: 1 spray into the mouth each 60 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter.
  • Under age 2: consult a health care professional.
Description

Active Ingredients: Agnus castus 6X, Avena sativa 1X, Cinchona officinalis 6X, Humulus lupulus 2X, Hyoscyamus niger 200C, Ignatia amara 200C, Passiflora incarnata 3X, Valeriana officinalis 3X

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 feelings of stress, including:

  • anxiety
  • nervousness
  • mood swings
  • irritability
Section 55106-9

Active Ingredients: Agnus castus 6X, Avena sativa 1X, Cinchona officinalis 6X, Humulus lupulus 2X, Hyoscyamus niger 200C, Ignatia amara 200C, Passiflora incarnata 3X, Valeriana officinalis 3X

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 feelings of stress, including:

° anxiety

° nervousness

° mood swings

° irritability

° natural

° gluten free

° no artificial flavors or colors

° no known negative side effects

° no known negative drug interactions

Dosage and Administration (34068-7)

Directions:

  • Adults and children over 12: 2 sprays into the mouth each 60 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
  • Ages 2 to 12: 1 spray into the mouth each 60 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter.
  • Under age 2: consult a health care professional.
Warnings and Precautions (34071-1)

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. 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 feelings of stress, including:

  • anxiety
  • nervousness
  • mood swings
  • irritability
Section 55106-9 (55106-9)

Active Ingredients: Agnus castus 6X, Avena sativa 1X, Cinchona officinalis 6X, Humulus lupulus 2X, Hyoscyamus niger 200C, Ignatia amara 200C, Passiflora incarnata 3X, Valeriana officinalis 3X

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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