FDA Label for Throatcalm
View Indications, Usage & Precautions
Throatcalm 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 3C HPUS (0.28 mg)
Arum triphyllum 3C HPUS (0.28 mg)
Belladonna 3C HPUS (0.28 mg) (contains less than 10 -8 mg atropine alkaloids)
Bromium 3C HPUS (0.28 mg) (contains less than 10 -6 mg bromine)
Bryonia 3C HPUS (0.28 mg)
Mercurius solubilis 4C HPUS (0.28 mg) (contains less than 10 -8 mg mercury)
Phytolacca decandra 3C HPUS (0.28 mg)
Pulsatilla 3C HPUS (0.28 mg)
Spongia tosta 3C HPUS (0.28 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 3C HPUS (0.28 mg)……..……Relieves hoarseness due to overexertion of the vocal cords
Arum triphyllum 3C HPUS (0.28 mg).…………….………..Relieves vocal cord fatigue in speakers and singers
Belladonna 3C HPUS (0.28 mg) ……………………....………………………………………..Relieves red and sore throat
Bromium 3C HPUS (0.28 mg)…………….………………………………………..…Relieves swollen and painful tonsils
Bryonia 3C HPUS (0.28 mg)….…………..…………………………………..…Relieves sore throat with intense thirst
Mercurius solubilis 4C HPUS (0.28 mg)…………………………..…Relieves sore throat with intense salivation
Phytolacca decandra 3C HPUS (0.28 mg)………….…Relieves sore throat with pain spreading to the ears
Pulsatilla 3C HPUS (0.28 mg)………………...………………..………………….……..………....Relieves raw sore throat
Spongia tosta 3C HPUS (0.28 mg)……………………..…….…………………..Relieves hoarseness with dry throat
Indications & Usage
Uses*
temporarily relieves occasional minor sore throat and hoarseness
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 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 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets in the mouth every 6 hours. Decrease frequency with improvement.
Other
Other information
- do not use if glued carton end flaps are open or if the blister seal is broken
- store below 86°F (30°C)
- retain carton for full drug facts
- Relieves Pain Without Numbing*
- No Aftertaste
SORE THROAT RELIEF*
Red, Dry, and Sore Throat
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
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron Inc.
Newtown Square, PA 19073
Package Label.Principal Display Panel
* Please review the disclaimer below.
