THROATCALM- arisaema triphyllum root, atropa belladonna, mercurius solubilis, bromine, bryonia alba root, arnica montana, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted pellet

THROATCALM by

Drug Labeling and Warnings

THROATCALM by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

WARNINGS

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.

STOP USE

Stop use and ask a doctor if symptoms persist for more than 2 days or worsen.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

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

SPL UNCLASSIFIED SECTION

• 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.

QUESTIONS

BoironUSA.com

Info@Boiron.com

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THROATCALM 
arisaema triphyllum root, atropa belladonna, mercurius solubilis, bromine, bryonia alba root, arnica montana, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9327
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM)	ARISAEMA TRIPHYLLUM ROOT	3 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_C]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	4 [hp_C]
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G)	BROMINE	3 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_C]
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_C]
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	3 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9327-42	2 in 1 BOX	05/09/2022
1	NDC: 0220-9327-41	80 in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/09/2022

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9327)