SNORE SOOTHE - histaminum hydrochloricum, lac caninum, arsenicum alb., belladonna, bryonia, camphora, cistus canadensis, drosera, hepar sulph.calc., hydrastis, ignatia, iodium, kali bic.,kali iod., nux vom., phosphorus, pulsatilla, sabadilla, silicea, sticta, sulphur, teucrium marum, verbascum, echinacea pellet 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Snore - Soothe

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 - 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.  

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

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.  

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.

PACKAGE LABEL

package label

SNORE SOOTHE  
histaminum hydrochloricum, lac caninum, arsenicum alb., belladonna, bryonia, camphora, cistus canadensis, drosera, hepar sulph.calc., hydrastis, ignatia, iodium, kali bic.,kali iod., nux vom., phosphorus, pulsatilla, sabadilla, silicea, sticta, sulphur, teucrium marum, verbascum, echinacea pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride15 [hp_X]  in 1 g
Canis Lupus Familiaris Milk (UNII: G39P120JQT) (Canis Lupus Familiaris Milk - UNII:G39P120JQT) Canis Lupus Familiaris Milk15 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 g
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna10 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
Camphor (natural) (UNII: N20HL7Q941) (Camphor (natural) - UNII:N20HL7Q941) Camphor (natural)10 [hp_X]  in 1 g
Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum Canadense10 [hp_X]  in 1 g
Drosera Rotundifolia Flowering Top (UNII: 75O014T1HG) (Drosera Rotundifolia Flowering Top - UNII:75O014T1HG) Drosera Rotundifolia Flowering Top10 [hp_X]  in 1 g
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide10 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal10 [hp_X]  in 1 g
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed10 [hp_X]  in 1 g
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine10 [hp_X]  in 1 g
Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate10 [hp_X]  in 1 g
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Iodide Ion10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 g
Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed10 [hp_X]  in 1 g
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide10 [hp_X]  in 1 g
Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T) Lobaria Pulmonaria10 [hp_X]  in 1 g
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur10 [hp_X]  in 1 g
Teucrium Marum (UNII: 10464S0TAA) (Teucrium Marum - UNII:10464S0TAA) Teucrium Marum10 [hp_X]  in 1 g
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus10 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2307-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-2307-256.7 g in 1 BOTTLE, GLASS
3NDC:55714-2307-07.08 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2307)

Revised: 3/2011
Document Id: 62f4d3a0-8a5f-eb2c-0fe3-f9356e2a5ddb
Set id: 5e4d6838-75b6-b001-d383-4cdfc98c566d
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.