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

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-HF

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

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

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

Warnings

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

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

Product Label Image

MENOPAUSE  HF
cimicifuga racemosa, trifolium pratense, magnesia carbonica, agnus castus tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64175-525
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh1 [hp_X]
Red Clover (UNII: L9153EKV2Y) (Red Clover - UNII:L9153EKV2Y) Red Clover1 [hp_X]
Magnesium Carbonate (UNII: 0E53J927NA) (Magnesium - UNII:I38ZP9992A) Magnesium Carbonate1 [hp_X]
Chaste Tree (UNII: 433OSF3U8A) (Chaste Tree - UNII:433OSF3U8A) Chaste Tree1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
Lactose (UNII: J2B2A4N98G)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorbrown (Light brown with dark brown speckels) Scoreno score
ShapeROUND (Tablet) Size11mm
FlavorImprint Code M
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64175-525-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/01/2010
Labeler - Foster Regal Laboratories (807396481)
Registrant - Dee Cee Laboratories (034731893)
Establishment
NameAddressID/FEIBusiness Operations
Dee Cee Laboratories034731893manufacture

Revised: 1/2012
Document Id: ad79d607-d040-4867-8334-3b8f9d71872f
Set id: cefb6780-75bc-4f52-8b93-ef94f63ca2c1
Version: 1
Effective Time: 20120131
 
Foster Regal Laboratories