FDA Label for Yeastaway
View Indications, Usage & Precautions
Yeastaway Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Boiron. 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
Borax 14X HPUS (0.15g), Calendula officinalis 1X HPUS (0.15g), Candida Albicans 30X HPUS (0.15g), Hydrastis canadensis 5X HPUS (0.15g)
(In each suppository)
(contains less than 10 -3 mg hydrastine and berberine alkaloids)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose
Borax 14X... Reduces thick vaginal discharge
Calendula officinalis 1X... Healing agent for vaginal mucosa
Candida Albicans 30X... Relieves symptoms of Candida (yeast) infection
Hydrastis canadensis 5X...Reduces vaginal discharge
Uses*
If this is the first time you have vaginal itching and discomfort, see your doctor to find out if you have a vaginal yeast infection.
Temporarily relieves symptoms of vaginal yeast infection (candidiasis), such as minor vaginal itching, burning, discomfort, discharge
Warnings
For vaginal use only.
Yeastaway may damage condoms and diaphragms and cause them to fail.
If swallowed, get medical help or contact a Poison Control Center right away
Otc - Ask Doctor
Ask a doctor before use if you
have one or more of the following:
Abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge.
Get vaginal yeast infections often (such as once a month or three in six months).
May have been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Are under 12 years of age.
Otc - When Using
When using this product
Do not use tampons, douche, spermicides
Do not have vaginal intercourse (sex).
Otc - Stop Use
Stop use and ask doctor if
symptoms do not improve in 3 days
symptoms remain after 7 days
you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling discharge or hives.
These may be signs that this product is not working, or you may have a more serious condition or an allergic reaction.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
Before using Yeastaway, read the enclosed educational brochure for complete instructions and information.
Adults and children 12 years of age and older: Insert one suppository high into the vagina every night for 7 consecutive nights.
Applicator is included.
Children under 12 years of age: Ask a doctor
Other Information
Do not use if the vaginal suppository seal is broken.
Do not store above 77 o F (25 o C)
Other
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Inactive Ingredients
Gelatin, glycerin, purified water.
Questions Or Comments?
BoironUSA.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
Newtown Square, PA
19073-3267
* Please review the disclaimer below.