Otc - Active Ingredient
Folliculinum 15C, Natrum muriaticum 12C, Sepia 12C
Cyclease Pms Tablet
FDA Label NDC 0220-9081
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Cyclease Pms (NDC 0220-9081). 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, indications & usage, otc - do not use, dosage & administration, inactive ingredient, how supplied, otc - purpose, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Temporary relieves premenstrual symptoms such as: discomfort, aches, bloating, irritability.
Otc - Do Not Use
Do not use if glued carton en flaps are open or if the blister seal is broken
Dosage & Administration
Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth morning
and evening until symptoms are relieved.
Children under 12 years of age: Not recommended
Inactive Ingredient
Croscarmellose sodium, lactose, magnesium stearate
How Supplied
60 tablets
Otc - Purpose
Folliculinum 15C ...Relieves discomfort and aches associated with PMS
Natrum muriaticum 12C ...Relieves water retention and irritability
Sepia 12C...Relieves bloating and lower back pain.
Storage And Handling
Store at 68-77
o F
Otc - Questions
Questions, Comments
www.boironusa.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Boiron Information Center
6 campus boulevard
Newtown Square, PA
19073-3267
Otc - Ask Doctor
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - When Using
Drug Interactions
Safe - no side effects - no drug interactions - works naturally with your body
Warnings
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