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NDC 61152-0195-60 SnoreStop 60 FastTabs 6; 6; 6; 12; 6; 6; 6 [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301 Details

SnoreStop 60 FastTabs 6; 6; 6; 12; 6; 6; 6 [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301

SnoreStop 60 FastTabs is a ORAL TABLET, CHEWABLE 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; HISTAMINE DIHYDROCHLORIDE; POTASSIUM DICHROMATE; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM.

Product Information

NDC	61152-0195
Product ID	61152-195_eb01551c-9f48-77a5-e053-2995a90a5a33
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 60 FastTabs
Proprietary Name Suffix	n/a
Non-Proprietary Name	atropa belladonna,ephedra distachya flowering twig,histamine dihydrochloride,goldenseal,potassium dichromate,strychnos nux-vomica seed,teucrium marum
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	6; 6; 6; 12; 6; 6; 6
Active Ingredient Units	[hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301; [hp_X]/301
Substance Name	ATROPA BELLADONNA; EPHEDRA DISTACHYA FLOWERING TWIG; GOLDENSEAL; HISTAMINE 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 61152-0195-60 (61152019560)

Pricing Information	N/A
NDC Package Code	61152-195-60
Billing NDC	61152019560
Package	60 TABLET, CHEWABLE in 1 PACKAGE (61152-195-60)
Marketing Start Date	2018-12-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 778c980b-cf6a-4f8d-9fa7-8732d7843d1a Details

Ingredients (HPUS):

Belladonna 6X, Ephedra vulg. 6X, Histaminum hydrochlorinum 12X, Hydrastatis 6X, Kali bic. 6X, Nux vom. 4X, 6X, Teucrium mar. 6X.

Inactive Ingredients:

Anhydrous Lactose, Croscarmellose sodium, Dextrose (45mg/tab), Lactose (180mg/tab), Magnesium Stearate, Microcrystalline Cellulose.

Uses:

Temporarily relieves symptoms of non-apneic snoring. Individual results may vary.

Warnings:

Use only as directed. Keep out of reach of children. Do not use on children under 5 years of age. If pregnant or breastfeeding, ask a doctor before use. This product does not treat sleep apnea. Stop use and ask a doctor if symptoms do not improve in 7 days.

Indications & Usage:

Chew or suck one tablet 30 minutes before bedtime and repeat at bedtime. When continuous improvement is noticed, you may start using every other night until no longer needed. In some cases, regular use may be more effective. For Maximum Results, use in conjunction with SnoreStop Naso Spray. May be used up to 4 times per day. Please discard 6 months after first use.

Keep out of reach of children.

Other information:

Store at room temperature in a cool dry place.
Use only if individual blister is unbroken.

Questions?

1-877-SNOREST

Directions: Children over 5 years of age and Adults

Snore Stop 60 Fast Tabs

INGREDIENTS AND APPEARANCE

SNORESTOP 60 FASTTABS

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61152-195
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 30
EPHEDRA DISTACHYA FLOWERING TWIG (UNII: R55VQ87DP3) (EPHEDRA DISTACHYA FLOWERING TWIG - UNII:R55VQ87DP3)	EPHEDRA DISTACHYA FLOWERING TWIG	6 [hp_X] in 30
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 30
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 30
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	6 [hp_X] in 30
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X] in 30
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	6 [hp_X] in 30

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	SS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61152-195-60	60 in 1 PACKAGE; 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		09/17/2012

Labeler - Green Pharmaceuticals Inc (937749265)

Registrant - Homeocare Laboratories (088248828)

Name	Address	ID/FEI	Business Operations
Establishment
Homeocare Laboratories		088248828	manufacture(61152-195)

Name	Address	ID/FEI	Business Operations
Establishment
Green Pharmaceuticals Inc		937749265	label(61152-195) , pack(61152-195)

Revised: 10/2022

Document Id: eb01551c-9f48-77a5-e053-2995a90a5a33

Set id: 778c980b-cf6a-4f8d-9fa7-8732d7843d1a

Version: 7

Effective Time: 20221014