Otc - Active Ingredient
Arnica montana 4C HPUS (0.5mg)
Cimicifuga racemosa 4C HPUS (0.5mg)
Glonoinum 4C HPUS (0.5mg)
Lachesis mutus 5C HPUS (0.5mg)
Sanguinaria canadensis 4C HPUS (0.5mg)
Cyclease Menopause Tablet
FDA Label NDC 0220-9082
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Cyclease Menopause (NDC 0220-9082). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Arnica montana 4C HPUS (0.5mg) ... Relieves red, blotchy face associated with hot flashes
Cimicifuga racemosa 4C HPUS (0.5mg) ... Relieves mood changes, irritability, and occassional sleeplessness associated with menopause.
Glonoinum 4C HPUS (0.5mg) ... Relieves sudden hot flashes with profuse sweating and throbbing headache associated with menopause
Lachesis mutus 5C HPUS (0.5mg) ... Relieves hot flashes, nigh sweats, irrability, and mood changes associated with menopause
Sanguinaria canadensis 4C HPUS (0.5mg) ... Relieves flushing of the face associated with menopause
Indications & Usage
temporarily relieves symptoms associated with perimenopause and menopause such as: hot flashes, red, blotchy or flushed face, night sweats, mood changes, irritability, occasional sleeplessness, temporarily reduces the intensity and frequency of hot flashes associated with perimenopause and menopause
Otc - Stop Use
Stop use and ask a doctor if symptoms persist or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults: At the onset of symptoms, day or night, allow 1 tablet to slowly dissolve in the mouth up to 4 times in 24 hours. Daily use for 3 months is recommended. Children: Not recommended.
Other
Do not use if glued carton end flaps are open or if the blister seal is broken.
Store below 86° F (30° C)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
*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.
60 meltaway tablets
Menapause relief*
Inactive Ingredient
lactose, magnesium stearate, sucrose
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
Made in France
* Please review the disclaimer below.
