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
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2307-0, 55714-2307-1, 55714-2307-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
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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.
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2307 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride 15 [hp_X] in 1 g Canis Lupus Familiaris Milk (UNII: G39P120JQT) (Canis Lupus Familiaris Milk - UNII:G39P120JQT) Canis Lupus Familiaris Milk 15 [hp_X] in 1 g Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 g Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 10 [hp_X] in 1 g Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [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 Canadense 10 [hp_X] in 1 g Drosera Rotundifolia Flowering Top (UNII: 75O014T1HG) (Drosera Rotundifolia Flowering Top - UNII:75O014T1HG) Drosera Rotundifolia Flowering Top 10 [hp_X] in 1 g Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 10 [hp_X] in 1 g Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 10 [hp_X] in 1 g Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K) Strychnos Ignatii Seed 10 [hp_X] in 1 g Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 10 [hp_X] in 1 g Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 10 [hp_X] in 1 g Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Iodide Ion 10 [hp_X] in 1 g Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 10 [hp_X] in 1 g Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X] in 1 g Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X] in 1 g Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed 10 [hp_X] in 1 g Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 10 [hp_X] in 1 g Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T) Lobaria Pulmonaria 10 [hp_X] in 1 g Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 10 [hp_X] in 1 g Teucrium Marum (UNII: 10464S0TAA) (Teucrium Marum - UNII:10464S0TAA) Teucrium Marum 10 [hp_X] in 1 g Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 10 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2307-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-2307-2 56.7 g in 1 BOTTLE, GLASS 3 NDC:55714-2307-0 7.08 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2307)
