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

Menopause by

Drug Labeling and Warnings

Menopause by is a Homeopathic medication manufactured, distributed, or labeled by New Sun Inc., King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

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

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

PURPOSE

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 INGREDIENT

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

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

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66579-0080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK)	AMYL NITRITE	10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	10 [hp_X]  in 59 mL
CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH)	CAULOPHYLLUM THALICTROIDES ROOT	10 [hp_X]  in 59 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	10 [hp_X]  in 59 mL
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	10 [hp_X]  in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X]  in 59 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	10 [hp_X]  in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]  in 59 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	10 [hp_X]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X]  in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X]  in 59 mL
SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF)	SULFURIC ACID	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66579-0080-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/22/2012

Labeler - New Sun Inc. (957251176)

Registrant - New Sun Inc. (957251176)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc.		617901350	manufacture(66579-0080)