Snore - soothe

Snore - soothe
SPL v1
SPL
SPL Set ID 5e4d6838-75b6-b001-d383-4cdfc98c566d
Route
ORAL
Published
Effective Date 2012-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Histamine (15 [hp_X]) Canis Lupus Familiaris Milk (10 [hp_X]) Arsenic Cation (3+) (3 [hp_X]) Atropa Belladonna Bryonia Alba Root Camphor (natural) Helianthemum Canadense Drosera Rotundifolia Flowering Top Calcium Sulfide Goldenseal Strychnos Ignatii Seed Iodine Dichromate Ion Iodide Ion Strychnos Nux-vomica Seed Phosphorus Pulsatilla Vulgaris Schoenocaulon Officinale Seed Silicon Dioxide Lobaria Pulmonaria Sulfur Teucrium Marum Verbascum Thapsus Echinacea, Unspecified
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Snore - Soothe  Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Purpose

 Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.


Medication Information

Purpose

 Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Description

Snore - Soothe  Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Package Label

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section

 Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.  

Indications & Usage Section

Snore - Soothe  Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Dosage & Administration Section

Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section

Histaminum hydrochloricum 15x, Lac caninum 15x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Camphora 10x, Cistus canadensis 10x, Drosera 10x, Hepar sulph.calc. 10x, Hydrastis 10x, Ignatia 10x, Iodium 10x, Kali bic. 10x, Kali iod. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Sabadilla 10x, Silicea 10x, Sticta 10x, Sulphur 10x, Teucrium marum 10x, Verbascum 10x, Echinacea 3x.

Otc Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.  

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256 

Otc Purpose Section (OTC - PURPOSE SECTION)

 Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.  

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Snore - Soothe  Formulated for symptoms associated with irregular airflow during sleep such as congestion, constriction, gland swelling, tension and inflammation.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Histaminum hydrochloricum 15x, Lac caninum 15x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Camphora 10x, Cistus canadensis 10x, Drosera 10x, Hepar sulph.calc. 10x, Hydrastis 10x, Ignatia 10x, Iodium 10x, Kali bic. 10x, Kali iod. 10x, Nux vom. 10x, Phosphorus 10x, Pulsatilla 10x, Sabadilla 10x, Silicea 10x, Sticta 10x, Sulphur 10x, Teucrium marum 10x, Verbascum 10x, Echinacea 3x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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