SNORE-SOOTHE- echinacea, bryonia, camphora, cistus canadensis, drosera, hepar sulphuris calcareum, hydrastis canadensis, ignatia amara, iodium, kali bichromicum, kali iodatum, phosphorus, pulsatilla, sabadilla, silicea, sticta pulmonaria, sulphur, teucrium marum, verbascum thapsus, arsenicum album, belladonna, histaminum hydrochloricum, lac caninum, nux vomica liquid 
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.

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Snore 2591L

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as congestion, constriction, gland swelling, tension and inflammation.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Camphora 15x, Cistus canadensis 15x, Drosera 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Ignatia 15x, Iodium 15x, Kali bic. 15x, Kali iod. 15x, Lac can. 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Sabadilla 15x, Silicea 15x, Sticta 15x, Sulphur 15x, Teucrium mar. 15x, Verbascum 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as congestion, constriction, gland swelling, tension and inflammation.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package label

SNORE-SOOTHE 
echinacea, bryonia, camphora, cistus canadensis, drosera, hepar sulphuris calcareum, hydrastis canadensis, ignatia amara, iodium, kali bichromicum, kali iodatum, phosphorus, pulsatilla, sabadilla, silicea, sticta pulmonaria, sulphur, teucrium marum, verbascum thapsus, arsenicum album, belladonna, histaminum hydrochloricum, lac caninum, nux vomica liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2591
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED6 [hp_X]  in 1 mL
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE15 [hp_X]  in 1 mL
DROSERA ANGLICA (UNII: J61BY05EGY) (DROSERA ANGLICA - UNII:J61BY05EGY) DROSERA ANGLICA15 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE15 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL15 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED15 [hp_X]  in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE15 [hp_X]  in 1 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE15 [hp_X]  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE15 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED15 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 [hp_X]  in 1 mL
LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR15 [hp_X]  in 1 mL
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM15 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS15 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA15 [hp_X]  in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE15 [hp_X]  in 1 mL
CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK15 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED15 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)15 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2591-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/19/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/19/2024
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610manufacture(55714-2591)

Revised: 3/2024
Document Id: 140a19fd-51d7-c90b-e063-6394a90a1745
Set id: 140a0bcf-82b3-c430-e063-6294a90ad38f
Version: 1
Effective Time: 20240319
 
Newton Laboratories, Inc.