MENOPAUSE- amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum liquid 
New Sun 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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Menopause

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Infants - 2 yrs. 1 Pump Spray

Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

Keep out of reach of children.

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Indications: For temporary relief of discomforts associated with menopause: •hot flashes •sweats •chills/clammy skin •heat in the head •headaches •hot feet •mood swings •anxiety/sensitivity •wanting to be alone

Active Ingredients: ​Amyl nitrosum, Calcarea carbonica, Caulophyllum thalictroides, Cimicifuga racemosa, Ferrum metallicum, Gelsemium sempervirens, Lachesis mutus, pulsatilla, Sanguinaria canadensis, Sepia, Sulphur, Sulphuricum acidum. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

Inactive Ingredient: Citric acid, potassium sorbate, purified water.

Indications: For temporary relief of discomforts associated with menopause:

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MENOPAUSE 
amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66579-0080
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK) AMYL NITRITE10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 59 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT10 [hp_X]  in 59 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 59 mL
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 59 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID10 [hp_X]  in 59 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66579-0080-259 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/22/2012
Labeler - New Sun Inc. (957251176)
Registrant - New Sun Inc. (957251176)
Establishment
NameAddressID/FEIBusiness Operations
King Bio Inc.617901350manufacture(66579-0080)

Revised: 10/2014
Document Id: c5335667-d8ef-4a77-b161-23f6fc099c18
Set id: dec91fdc-001c-44e6-abff-2685754f4b55
Version: 1
Effective Time: 20141024
 
New Sun Inc.