FDA Label for Menopause HF
View Indications, Usage & Precautions
Menopause HF Product Label
The following document was submitted to the FDA by the labeler of this product Foster Regal Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Cimicifuga racemosa 1X HPUS Trifolium pratense 1X HPUS Magnesia carbonica 1X HPUS Agnus castus 1X HPUS
Otc - Purpose
Relieves hot flashes andmood changesSupportive phytoestrogens,isoflavones for other ingredientsRelieves cramps, nervousness,and muscle spasmsImproves melancholy andperimenopausal hormone imbalance
Otc - 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
WarningsAllergy 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 extradose may be taken at bedtime if needed. Do not exceed 10tablets in a 24 hour period. The smallest effective dose shouldbe used. Do not give to children under 12. Do not exceedrecommended dose.Other Information:B-complex vitamins are complementary when used withinthe same day as this drug. 1X indicates a 1:9 homeopathicdiluted ingredient. The letters HPUS indicate that these ingre-dients are officially included in the HomeopathicPharmacopeia of the United States. Store at controlled roomtemperature 59-86F (15-30 C) Do not use if imprintedsafety seal under cap is broken or missing.
Inactive Ingredient
Inactive ingredients: Lactose, vegetable stearic acid, vegetablecellulose, vegetable magnesium stearate.
Package Label.Principal Display Panel
* Please review the disclaimer below.