The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Throatcalm (NDC 0220-9329). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Purpose*
Echinacea 1X HPUS (0.01 mL) ... Relieves sore throat pain
Plantago major 1X HPUS (0.01 mL) ... Relieves sore throat pain
Uses*
temporarily relieves occasional minor sore throat pain
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.
When using this product do not exceed recommended dosage.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
alcohol, glycerin, L-carvone, purified water
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.
Questions or comments?
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073
Made in Belgium
* Please review the disclaimer below.
