Active ingredient A list of the active, medicinal ingredients in the drug product.
Paeonia officinalis 30C (**contains 0.443 mg of the active ingredient per pellet)
Dosage and administration Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.
Inactive ingredient A list of inactive, non-medicinal ingredients in a drug product.
Indications and usage A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Spl product data elements Usually a list of ingredients in a drug product.
Paeonia officinalis PAEONIA OFFICINALIS ROOT SUCROSE PAEONIA OFFICINALIS ROOT PAEONIA OFFICINALIS ROOT LACTOSE, UNSPECIFIED FORM ANHYDROUS LACTOSE
Package label principal display panel The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Spl unclassified section Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
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.
Keep out of reach of children Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children
Questions A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
Stop use Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen
Pregnancy or breast feeding Pregnancy or Breast feeding
If pregnant or breast-feeding ask a health professional before use