Otc - Active Ingredient
VIBURNUM OPULUS 9C
(**contains 0.443 mg of the active ingredient per pellet)
Viburnum Opulus Pellet
FDA Label NDC 0220-5259
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 Viburnum Opulus (NDC 0220-5259). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, other, inactive ingredient, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Painful menstruation with light flow*
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
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
Other
Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*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 Ingredient
lactose, sucrose
Dosage & Administration
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
Package Label.Principal Display Panel
Label (Vibopu9c)
* Please review the disclaimer below.
