The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Bone Pain Relief (NDC 0220-9103). 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, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each pellet)
Calcarea phosphorica 30C HPUS (0.44 mg)
Symphytum officinale 6C HPUS (0.44 mg)
(contains less than 10 -12 pyrrolizidine alkaloids)
The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Calcarea phosphorica 30C HPUS (0.44 mg)……….Relieves minor aches and discomfort associated with growing bone pain
Symphytum officinale 6C HPUS (0.44 mg)…………….…Relieves minor pain associated with bone trauma
Uses*
▪ temporarily relieves minor pain associated with bone trauma and minor aches and discomfort associated with growing bone pain
Ask a doctor before use if
• pain in child does not seem like typical growing pains
• pain is severe
• numbness is present
• any bone has broken through the skin
• head injury is suspected
These could be signs of a fracture or a serious injury requiring a doctor's care.
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
▪ Adults and children 12 years of age and older:
For minor pain associated with bone trauma: At the onset of symptoms, dissolve 5 pellets each of Calcarea phosphorica 30C and Symphytum officinale 6C under the tongue 3 times a day or as directed by a doctor.
For minor aches and discomfort associated with growing bone pain: At the onset of symptoms, dissolve 5 pellets of Calcarea phosphorica 30C under the tongue 3 times a day or as directed by a doctor.
▪ Children under 12 years of age: Ask a doctor.
lactose, sucrose
▪ do not use if glued carton end flaps are open or if pellet dispenser seal is broken
▪ contains 0.25 g of sugar per dose
▪ retain carton for full drug facts
BONE PAIN RELIEF KIT*
Minor Pain ▪ Minor Trauma*
3 TUBES
APPROX. 80 PELLETS EACH
TOTAL 240 PELLETS
No Known Drug Interactions
No NSAIDs
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
Turn tube upside down
Twist until 5 pellets are dispensed
Remove cap and 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.
* Please review the disclaimer below.
