Label: THROATCALM- echinacea angustifolia whole, plantago major whole spray
- NDC Code(s): 0220-9329-77
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 10, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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.
- Decrease frequency with improvement.
- Children under 12 years of age: Ask a doctor.
- INACTIVE INGREDIENT
-
SPL UNCLASSIFIED SECTION
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)
1 spray per dose
25.2% ALCOHOL*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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THROATCALM
echinacea angustifolia whole, plantago major whole sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9329 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 1 [hp_X] in 1 mL PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR WHOLE - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CARVONE, (-)- (UNII: 5TO7X34D3D) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9329-77 1 in 1 BOX 02/24/2023 1 20 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/24/2023 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9329)
