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 ingredient** (in each pellet)
Arnica montana 3C HPUS (0.05 mg)
Arum triphyllum 3C HPUS (0.05 mg)
Belladonna 3C HPUS (0.05 mg) (contains less than 10-9 mg atropine alkaloids)
Bromium 3C HPUS (0.05 mg) (contains less than 10-7 mg bromine)
Bryonia 3C HPUS (0.05 mg)
Mercurius solubilis 4C HPUS (0.05 mg) (contains less than 10-9 mg mercury)
Phytolacca decandra 3C HPUS (0.05 mg)
Pulsatilla 3C HPUS (0.05 mg)
Spongia tosta 3C HPUS (0.05 mg)
The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia on the United States.
Otc - Purpose
Purpose*
Relieves Sore Throat Symptoms: Red and Dry Throat, Raw Sore Throat, Hoarseness, Swollen Tonsils
Indications & Usage
Uses*
temporarily relieves minor sore throat and hoarseness
Otc - Ask Doctor
Ask a doctor before use:
- in children under 3 years of age
- if sore throat is severe, accompanied or followed by fever, headache, rash, nausea, or vomiting.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, 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 3 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, take 5 pellets every 6 hours. Decrease frequency with improvement.
Inactive Ingredient
lactose, sucrose
Other
- 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
Sore Throat Relief*
Relieves Pain Without Numbing*
No Aftertaste
2 PORTABLE TUBES
APPROX. 80 PELLETS EACH
TOTAL 160 PELLETS
Contains approx. 80 pellets, 3.8 g (0.13 oz)
Turn tube upside down
Twist until 5 pellets are dispensed
Remove cap and pour pellets under the tongue
Do not use if pellet dispenser seal is broken,
*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.
Otc - Questions
BoironUSA.com
1-800-264-7661
Made in France
Distributed by
Boiron Inc.
Newtown Square, PA 19073
* Please review the disclaimer below.
