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** (one spray)
Echinacea 1X HPUS (0.01 mL)
Plantago major 1X HPUS (0.01 mL)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Purpose*
Echinacea 1X HPUS (0.01 mL) ... Relieves sore throat pain
Plantago major 1X HPUS (0.01 mL) ... Relieves sore throat pain
Indications & Usage
Uses*
temporarily relieves occasional minor sore throat pain
Warnings
Sore Throat Warning: Severe or persistent 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 12 years of age unless directed by a doctor.
Otc - When Using
When using this product do not exceed recommended dosage.
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
Directions
- Adults and children 12 years of age and older:
- At the onset of symptoms, apply to the affected area (one spray).
- Keep in mouth for at least 15 seconds, then swallow.
- Use up to 6 times a day until symptoms are relieved.
- Children under 12 years of age: Ask a doctor.
Inactive Ingredient
alcohol, glycerin, L-carvone, purified water
Other
Sore Throat Relief*
Targeted, Soothing Relief
Herbal Mint Flavor
do not use if glued carton end flaps are open or if the plastic sleeve around container is broken or missing
store below 77 o F (25 o C)
retain this carton for full directions
0.68 fl oz
(20 mL)
25.2% ALCOHOL
1 Spray per Dose
Hold the bottle with the pump facing up.
Rotate the spray rod horizontally or vertically to your preferred position.
Before first use, prime the pump by pressing 3 to 4 times outside the mouth.
Spray affected area.
It is recommended to clean the spray rod after each use.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C, K, CK and X are homeopathic dilutions: see BoironUSA.com/info for details.
Otc - Questions
Questions or comments?
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
Made in Belgium
Package Label.Principal Display Panel
* Please review the disclaimer below.