FDA Label for Voicecalm
View Indications, Usage & Precautions
Voicecalm Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients** (in each tablet)
Arnica montana 9C HPUS (0.42 mg)
Arum triphyllum 9C HPUS (0.42 mg)
Ferrum phosphoricum 9C HPUS (0.42 mg)
Hepar sulphuris calcareum 30C HPUS (0.42 mg)
Rhus tox 9C HPUS (0.42 mg)
Spongia tosta 9C HPUS (0.42 mg)
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Arnica montana 9C HPUS (0.42 mg)……………………Relieves hoarseness due to overexertion of the vocal cords
Arum triphyllum 9C HPUS (0.42 mg)……Relieves hoarseness with broken voice
Ferrum phosphoricum 9C HPUS (0.42 mg) ……..Relieves dry tickling throat due to vocal strain
Hepar sulphuris calcareum 30C HPUS (0.42 mg)…..Relieves painful swallowing and sensation of splinter in the throat
Rhus tox 9C HPUS (0.42 mg)…………………. Relieves hoarseness at the start of speaking or singing
Spongia tosta 9C HPUS (0.42 mg)…………. Relieves dry throat with barking cough
Indications & Usage
Uses*
temporarily relieves:
- hoarseness
- loss of voice associated with vocal strain
- occasional minor throat irritation
Warnings
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.
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
- Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every hour, up to 6 times per day. Reduce frequency with improvement.
- Children under 6 years of age: Ask a doctor.
Other
Other information
- do not use if glued carton end flaps are open or if blister seal is broken
- store below 86°F (30°C)
- Relieves Without Numbing
- No Water Needed
VOCAL STRAIN RELIEF*
Loss of Voice • Hoarseness*
60 Meltaway Tablets
*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
croscarmellose sodium, lactose, magnesium stearate
Otc - Questions
Questions or comments?
BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
