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NDC 61152-0199-99 SnoreStop NasoSpray 60 6; 6; 6; 12; 6; 6; 6 [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL Details

SnoreStop NasoSpray 60 6; 6; 6; 12; 6; 6; 6 [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL

SnoreStop NasoSpray 60 is a NASAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Green Pharmaceuticals Inc.. The primary component is ATROPA BELLADONNA; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; N.ALPHA.-METHYLHISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM.

Product Information

NDC	61152-0199
Product ID	61152-199_e194696f-0a7f-f303-e053-2a95a90a3c90
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SnoreStop NasoSpray 60
Proprietary Name Suffix	n/a
Non-Proprietary Name	strychnos nux-vomica seed,atropa belladonna,ephedra distachya flowering twig,goldenseal,potassium dichromate,teucrium marum,histamine dihydrochloride liquid
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	NASAL
Active Ingredient Strength	6; 6; 6; 12; 6; 6; 6
Active Ingredient Units	[hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL; [hp_X]/9mL
Substance Name	ATROPA BELLADONNA; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; N.ALPHA.-METHYLHISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM
Labeler Name	Green Pharmaceuticals Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 61152-0199-99 (61152019999)

Pricing Information	N/A
NDC Package Code	61152-199-99
Billing NDC	61152019999
Package	9 mL in 1 BOTTLE, SPRAY (61152-199-99)
Marketing Start Date	2018-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f4d26053-32aa-4cc9-8460-556acc38fe33 Details

Ingredients:

Nux Vomica 4X,6X, Belladonna 6X, Ephedra 6X, Hydrastis canadensis 6X, Kali bich. 6X, Teucrium marum 6X, Histaminium 12X.

Base:

Benzalkonium chloride, Glycerin, Potassium chloride, Potassium phospate, Purified water, Sodium chloride, Sodium phosphate.

Directions:

Adults and children over 5 years old. Shake before each use. At bedtime, spray once into each nostril. Store below 30 degrees C.

Directions: Children over 5 years of age and Adults.

Shake before use. 1. Remove cap and safety clip. 2. Prime by placing nozzle between first and second finger with thumb on the bottom of the bottle. Pump sprayer firmly and quickly until a fine spray appears. 3. Insert spray tip into one nostril, pointing the tip toward the back of the nose. Spray quickly while breathing in through your nose. Clean tip of nozzle after each use and replace cap. Store at room temperatur. May be used up to 4 times per day. Please discard 6 months after first use.

For Maximum Results, use in conjunction with SnoreStop FastTabs or SnoreStop Extinguisher.

Warnings:

Use only as directed. Keep this out of reach of children. Do not use on children under 5 years of age. If pregnant or breastfeeding, ask a physician before use. This product does not treat sleep apnea. For sleep apnea, consult with a specialist. If symptoms worsen after 14 days, discontinue use and ask a physician for help.

Comments or Questions?

Toll free 1-877-SNOREST

email: [email protected]

Visit: www.snorestop.com

Keep out of reach of children.

Uses:

Temporarily helps stop or reduce symptoms of non-apneic snoring. Individual results may vary.

NasoSpray 60

INGREDIENTS AND APPEARANCE

SNORESTOP NASOSPRAY 60

strychnos nux-vomica seed,atropa belladonna,ephedra distachya flowering twig,goldenseal,potassium dichromate,teucrium marum,histamine dihydrochloride liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61152-199
Route of Administration	NASAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X] in 9 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 9 mL
EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3)	EPHEDRA DISTACHYA FLOWERING TWIG	6 [hp_X] in 9 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 9 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X] in 9 mL
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	6 [hp_X] in 9 mL
N.ALPHA.-METHYLHISTAMINE DIHYDROCHLORIDE (UNII: S6S98U0517) (HISTAMINE - UNII:820484N8I3)	N.ALPHA.-METHYLHISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 9 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM (UNII: 7N6JUD5X6Y)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61152-199-99	9 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/19/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/18/2012

Labeler - Green Pharmaceuticals Inc. (937749265)

Registrant - Homeocare Laboratories (088248828)

Name	Address	ID/FEI	Business Operations
Establishment
HomeoCare Laboratories, Inc.		088248828	manufacture(61152-199)

Name	Address	ID/FEI	Business Operations
Establishment
Green Pharmaceuticals Inc.		937749265	label(61152-199)

Name	Address	ID/FEI	Business Operations
Establishment
Coastal Contract Packaging		137341611	pack(61152-199)

Revised: 6/2022

Document Id: e194696f-0a7f-f303-e053-2a95a90a3c90

Set id: f4d26053-32aa-4cc9-8460-556acc38fe33

Version: 4

Effective Time: 20220616