CYCLEASE MENOPAUSE- arnica montana whole, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root tablet

Cyclease Menopause by

Drug Labeling and Warnings

Cyclease Menopause by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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

WARNINGS

ASK DOCTOR

STOP USE

Stop use and ask a doctor if symptoms persist or worsen.

PREGNANCY OR BREAST FEEDING

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

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.

SPL UNCLASSIFIED SECTION

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

QUESTIONS

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

Made in France

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CYCLEASE MENOPAUSE 
arnica montana whole, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9082
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	4 [hp_C]
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	5 [hp_C]
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	4 [hp_C]
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	4 [hp_C]
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	4 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	Boiron
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9082-04	60 in 1 CARTON	04/01/2020
1		60 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/01/2020

Labeler - Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9082)