Sleep Eezzz

Sleep Eezzz
SPL v1
SPL
SPL Set ID 25fc2303-8e04-476e-b407-d8abea37068b
Route
ORAL
Published
Effective Date 2014-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Arsenic Cation (3+) Avena Sativa Flowering Top Atropa Belladonna Camphor (natural) Cinchona Officinalis Bark Arabica Coffee Bean Cypripedium Parvifolum Root Hyoscyamus Niger Passiflora Incarnata Flowering Top Pulsatilla Vulgaris Valerian
Inactive Ingredients
Citric Acid Monohydrate Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-07-30

Description

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve. Adult Dose: 3 Pump Sprays Child's Dose: (2-12): 2 Pump Sprays Infants-2 yrs: 1 Pump Spray


Medication Information

Warnings and Precautions

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

Indications and Usage

Indications: For temporary relief of: restlessness •inability to fall asleep •sleeplessness •tossing & turning •light sleeping •overactive mind •tension/anxiety •disturbed sleep •unrefreshing sleep •nightly itching & muscular spasms

Dosage and Administration

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose: (2-12): 2 Pump Sprays

Infants-2 yrs: 1 Pump Spray

Description

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve. Adult Dose: 3 Pump Sprays Child's Dose: (2-12): 2 Pump Sprays Infants-2 yrs: 1 Pump Spray

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

Section 51945-4

Section 55105-1

Indications: For temporary relief of: •restlessness •inability to fall asleep •sleeplessness •tossing & turning •light sleeping •overactive mind •tension/anxiety •disturbed sleep •unrefreshing sleep •nightly itching & muscular spasms

Section 55106-9

Active Ingredients: ​Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Passiflora incarnata, Pulsatilla, Valeriana officinalis. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

Section 60561-8

Other information: Tamper resistant for your protection. Use only if safety seal is intact.


Structured Label Content

Indications and Usage (34067-9)

Indications: For temporary relief of: restlessness •inability to fall asleep •sleeplessness •tossing & turning •light sleeping •overactive mind •tension/anxiety •disturbed sleep •unrefreshing sleep •nightly itching & muscular spasms

Dosage and Administration (34068-7)

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose: (2-12): 2 Pump Sprays

Infants-2 yrs: 1 Pump Spray

Warnings and Precautions (34071-1)

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, take only on advice of physician.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Indications: For temporary relief of: •restlessness •inability to fall asleep •sleeplessness •tossing & turning •light sleeping •overactive mind •tension/anxiety •disturbed sleep •unrefreshing sleep •nightly itching & muscular spasms

Section 55106-9 (55106-9)

Active Ingredients: ​Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Passiflora incarnata, Pulsatilla, Valeriana officinalis. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

Section 60561-8 (60561-8)

Other information: Tamper resistant for your protection. Use only if safety seal is intact.


Advanced Ingredient Data


Raw Label Data

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