The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Voicecalm (NDC 0220-9331). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each pellet)
Arnica montana 9C HPUS (0.07 mg)
Arum triphyllum 9C HPUS (0.07 mg)
Ferrum phosphoricum 9C HPUS (0.07 mg)
Hepar sulphuris calcareum 30C HPUS (0.07 mg)
Rhus tox 9C HPUS (0.07 mg)
Spongia tosta 9C HPUS (0.07 mg)
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Relieves Hoarseness, Loss of Voice, and Occasional Minor Throat Irritation
Uses*
temporarily relieves:
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.
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.
VOCAL STRAIN RELIEF*
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Turn tube upside down & twist cap.
*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.
lactose, sucrose
BoironUSA.com
1-800-264-7661
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
