Active Ingredients
Arnica montana 3C, Arum triphyllum 3C, Belladonna 3C, Bromium 3C, Bryonia 3C, Mercuris solubilis 4C, Phytolacca decandra 3C, Pulsatilla 3C, Spongia tosta 3C
Throatcalm Tablet
FDA Label NDC 0220-9325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Throatcalm (NDC 0220-9325). 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 active ingredients, purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Arnica montana 3C Relieves hoarseness due to overexertion of the vocal cords
Arum triphyllum 3C Relieves vocal cord fatigue in speakers and singers
Belladonna 3C Relieves red and sore throat
Bromium 3C Relieves swollen and painful tonsils
Bryonia alba 3C Relieves sore throat with intense thirst
Mercuris solubilis 4C Relieves sore throat with intense salivation
Phytolacca decandra 3C Relieves sore throat with pain spreading to the ears
Pulsatilla 3C Relieves raw sore throat
Spongia tosta 3C Relieves hoarseness with dry throat
Uses
Temporary relieves minor sore throat and hoarseness.
Otc - Ask Doctor
Ask a doctor before use in children under 12 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 doctor if symptoms persist for more than 2 days or worsen.
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
Directions
Adults and children 12 years of age and older:
At the onset of symptoms, dissolve 2 tablets under the tongue every 15 minutes for 1 hour.
Then, dissolve 2 tablets under the tongue 3 times a day until symptoms are relieved.
Children under 12 years of age: Ask a doctor.
Other Information
Do not use if glued carton end flaps are open or if the blister seal is broken
Do not store above 86o F (30o C)
Inactive Ingredient
croscarmellose sodium, lactose, magnesium stearate
Questions Or Comments?
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19073-3267
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