FDA Label for Dysfunctional Bleeding Drops 2138

View Indications, Usage & Precautions

Dysfunctional Bleeding Drops 2138 Product Label

The following document was submitted to the FDA by the labeler of this product Professional Complementary Health Formulas. 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.

Active Ingredients



Hypothalamus 6X
Liver 6X
Ovary 6X
Pituitary 6X
Spleen 6X
Uterus 6X
Agnus castus 8X
Coffea tosta 8X
Calendula officinalis 9X
Hydrastis canadensis 9X
Capsella bursa-pastoris 12X
Endometritis tuberculosa 12X
Helonias luteum 12X
Silicea 12X
Trifolium pratense 12X
Viburnum opulus 12X
Apis mellifica 30X
Cactus grandiflorus 30X
Collinsonia canadensis 30X
Gelsemium sempervirens 30X
Nux vomica 30X
Veratrum album 30X


Questions



Professional Formulas

PO Box 2034 Lake Oswego, OR 97035


Indications



For the temporary relief of occasional mild spotting or menstrual irregularity.*


Otc - Purpose



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings



Any significant vaginal bleeding or change in menstrual pattern requires evaluation by a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a healthcare professional before use.


Directions



Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.


Other Information



Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.


Inactive Ingredients



20% ethanol, purified water.


Label



Est 1985

Professional Formulas

Complementary Health

Dysfunctional Bleeding Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)


* Please review the disclaimer below.