MENOPAUSE HF- cimicifuga racemosa, trifolium pratense, magnesia carbonica, agnus castus tablet

Menopause by

Drug Labeling and Warnings

Menopause by is a Homeopathic medication manufactured, distributed, or labeled by Foster Regal Laboratories, Dee Cee Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Cimicifuga racemosa 1X HPUS       
Trifolium pratense 1X HPUS             
Magnesia carbonica 1X HPUS           
Agnus castus 1X HPUS

PURPOSE

Relieves hot flashes and
mood changes

Supportive phytoestrogens,
isoflavones for other ingredients

Relieves cramps, nervousness,
and muscle spasms

Improves melancholy and
perimenopausal hormone imbalance

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Uses:Relieves hot flashes, mood changes associated with perimenopausal hormone changes.

WARNINGS

Warnings

Allergy Alert: Rare allergic reaction to Red clover (Trifolium pratense): includes skin reactions; to Black Cohosh (Cimicfuga racemosa): includes stomach discomfort.

DOSAGE & ADMINISTRATION

Directions:
Adults take 1 or 2 tablets 3 times daily with meals.  An extra
dose may be taken at bedtime if needed.  Do not exceed 10
tablets in a 24 hour period.  The smallest effective dose should
be used.  Do not give to children under 12.  Do not exceed
recommended dose.

Other Information:
B-complex vitamins are complementary when used within
the same day as this drug.  1X indicates a 1:9 homeopathic
diluted ingredient.  The letters HPUS indicate that these ingre-
dients are officially included in the Homeopathic
Pharmacopeia of the United States.  Store at controlled room
temperature 59-86F (15-30 C)  Do not use if imprinted
safety seal under cap is broken or missing.

INACTIVE INGREDIENT

Inactive ingredients: Lactose, vegetable stearic acid, vegetable
cellulose, vegetable magnesium stearate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENOPAUSE  HF
cimicifuga racemosa, trifolium pratense, magnesia carbonica, agnus castus tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64175-525
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9)	Black Cohosh	1 [hp_X]
Red Clover (UNII: L9153EKV2Y) (Red Clover - UNII:L9153EKV2Y)	Red Clover	1 [hp_X]
Magnesium Carbonate (UNII: 0E53J927NA) (Magnesium - UNII:I38ZP9992A)	Magnesium Carbonate	1 [hp_X]
Chaste Tree (UNII: 433OSF3U8A) (Chaste Tree - UNII:433OSF3U8A)	Chaste Tree	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
Lactose (UNII: J2B2A4N98G)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	brown (Light brown with dark brown speckels)	Score	no score
Shape	ROUND (Tablet)	Size	11mm
Flavor		Imprint Code	M
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64175-525-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/01/2010

Labeler - Foster Regal Laboratories (807396481)

Registrant - Dee Cee Laboratories (034731893)

Establishment
Name	Address	ID/FEI	Business Operations
Dee Cee Laboratories		034731893	manufacture