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  5. Label Information: Menopause

FDA Label for Menopause

View Indications, Usage & Precautions

Table of Contents

    1. DOSAGE & ADMINISTRATION
    2. WARNINGS
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. OTHER SAFETY INFORMATION
    5. OTC - PURPOSE
    6. OTC - ACTIVE INGREDIENT
    7. INACTIVE INGREDIENT
    8. INDICATIONS & USAGE
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Menopause Product Label

The following document was submitted to the FDA by the labeler of this product New Sun Inc.. 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.

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.


Otc - 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.


Otc - 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


Otc - 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

Package Label.Principal Display Panel



image description - menopause

image description - menopause


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