Throatcalm

Throatcalm
SPL v10
SPL
SPL Set ID 94afc290-2d11-11e7-818d-424c58303031
Route
ORAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_C]) Arisaema Triphyllum Root (4 [hp_C]) Belladonna Leaf Bromine Bryonia Alba Root Spongia Officinalis Skeleton, Roasted Mercurius Solubilis Phytolacca Americana Root Pulsatilla Vulgaris
Inactive Ingredients
Croscarmellose Sodium Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-05-01

Description

Active ingredients** (in each tablet) Arnica montana 3C HPUS (0.28 mg) Arum triphyllum 3C HPUS (0.28 mg) Belladonna 3C HPUS (0.28 mg) (contains less than 10 -8 mg atropine alkaloids) Bromium 3C HPUS (0.28 mg) (contains less than 10 -6 mg bromine) Bryonia 3C HPUS (0.28 mg) Mercurius solubilis 4C HPUS (0.28 mg) (contains less than 10 -8 mg mercury) Phytolacca decandra 3C HPUS (0.28 mg) Pulsatilla 3C HPUS (0.28 mg) Spongia tosta 3C HPUS (0.28 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Purpose* Arnica montana 3C HPUS ... Relieves hoarseness due to overexertion of the vocal cords Arum triphyllum 3C HPUS ... Relieves vocal cord fatigue in speakers and singers Belladonna 3C HPUS ... Relieves red and sore throat Bromium 3C HPUS ... Relieves swollen and painful tonsils Bryonia 3C HPUS ... Relieves sore throat with intense thirst Mercuris solubilis 4C HPUS ... Relieves sore throat with intense salivation Phytolacca decandra 3C HPUS ... Relieves sore throat with pain spreading to the ears Pulsatilla 3C HPUS ... Relieves raw sore throat Spongia tosta 3C HPUS ... Relieves hoarseness with dry throat


Medication Information

Warnings and Precautions

Sore Throat Warning: Severe or persistent sore 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 4 years of age unless directed by a doctor.

Purpose

Purpose*

Arnica montana 3C HPUS ... Relieves hoarseness due to overexertion of the vocal cords



Arum triphyllum 3C HPUS ... Relieves vocal cord fatigue in speakers and singers



Belladonna 3C HPUS ... Relieves red and sore throat



Bromium 3C HPUS ... Relieves swollen and painful tonsils



Bryonia 3C HPUS ... Relieves sore throat with intense thirst



Mercuris solubilis 4C HPUS ... Relieves sore throat with intense salivation



Phytolacca decandra 3C HPUS ... Relieves sore throat with pain spreading to the ears



Pulsatilla 3C HPUS ... Relieves raw sore throat



Spongia tosta 3C HPUS ... Relieves hoarseness with dry throat

Description

Active ingredients** (in each tablet) Arnica montana 3C HPUS (0.28 mg) Arum triphyllum 3C HPUS (0.28 mg) Belladonna 3C HPUS (0.28 mg) (contains less than 10 -8 mg atropine alkaloids) Bromium 3C HPUS (0.28 mg) (contains less than 10 -6 mg bromine) Bryonia 3C HPUS (0.28 mg) Mercurius solubilis 4C HPUS (0.28 mg) (contains less than 10 -8 mg mercury) Phytolacca decandra 3C HPUS (0.28 mg) Pulsatilla 3C HPUS (0.28 mg) Spongia tosta 3C HPUS (0.28 mg) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

Uses*

temporarily relieves occasional minor sore throat and hoarseness

Section 42229-5

do not use if glued carton end flaps are open or if the blister seal is broken

do not store above 86 oF (30 oC)

Sore Throat Relief*

Red, Dry,and Sore Throat Hoarseness*

Relieves Pain Without Numbing*

For Ages 4+ Years

No Aftertaste

60 Meltaway tablets unflavored

100 Meltaway tablets unflavored

120 Meltaway tablets unflavored

*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.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, take 2 tablets every 6 hours. Decrease frequency with improvement.



Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

Other Information

do not use if glued carton end flaps are open or if the blister seal is broken



do not store above 86 o F (30 o C)

Active Ingredients

Active ingredients** (in each tablet)

Arnica montana 3C HPUS (0.28 mg)

Arum triphyllum 3C HPUS (0.28 mg)

Belladonna 3C HPUS (0.28 mg) (contains less than 10 -8 mg atropine alkaloids)

Bromium 3C HPUS (0.28 mg) (contains less than 10 -6 mg bromine)

Bryonia 3C HPUS (0.28 mg)

Mercurius solubilis 4C HPUS (0.28 mg) (contains less than 10 -8 mg mercury)

Phytolacca decandra 3C HPUS (0.28 mg)

Pulsatilla 3C HPUS (0.28 mg)

Spongia tosta 3C HPUS (0.28 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredient

croscarmellose sodium, lactose, magnesium stearate

Questions Or Comments?

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)



Distributed by Boiron Inc.

Newtown Square, PA 19073

Principle Display Panel Throatcalm


Structured Label Content

Uses

Uses*

temporarily relieves occasional minor sore throat and hoarseness

Warnings and Precautions (34071-1)

Sore Throat Warning: Severe or persistent sore 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 4 years of age unless directed by a doctor.

Section 42229-5 (42229-5)

do not use if glued carton end flaps are open or if the blister seal is broken

do not store above 86 oF (30 oC)

Sore Throat Relief*

Red, Dry,and Sore Throat Hoarseness*

Relieves Pain Without Numbing*

For Ages 4+ Years

No Aftertaste

60 Meltaway tablets unflavored

100 Meltaway tablets unflavored

120 Meltaway tablets unflavored

*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.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Purpose*

Arnica montana 3C HPUS ... Relieves hoarseness due to overexertion of the vocal cords



Arum triphyllum 3C HPUS ... Relieves vocal cord fatigue in speakers and singers



Belladonna 3C HPUS ... Relieves red and sore throat



Bromium 3C HPUS ... Relieves swollen and painful tonsils



Bryonia 3C HPUS ... Relieves sore throat with intense thirst



Mercuris solubilis 4C HPUS ... Relieves sore throat with intense salivation



Phytolacca decandra 3C HPUS ... Relieves sore throat with pain spreading to the ears



Pulsatilla 3C HPUS ... Relieves raw sore throat



Spongia tosta 3C HPUS ... Relieves hoarseness with dry throat

Directions

Adults and children 6 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, take 2 tablets every 6 hours. Decrease frequency with improvement.



Children 4 to under 6 years of age: Dissolve 2 tablets in 1 tablespoon of water for easier intake. Follow directions above.

Other Information (Other information)

do not use if glued carton end flaps are open or if the blister seal is broken



do not store above 86 o F (30 o C)

Active Ingredients

Active ingredients** (in each tablet)

Arnica montana 3C HPUS (0.28 mg)

Arum triphyllum 3C HPUS (0.28 mg)

Belladonna 3C HPUS (0.28 mg) (contains less than 10 -8 mg atropine alkaloids)

Bromium 3C HPUS (0.28 mg) (contains less than 10 -6 mg bromine)

Bryonia 3C HPUS (0.28 mg)

Mercurius solubilis 4C HPUS (0.28 mg) (contains less than 10 -8 mg mercury)

Phytolacca decandra 3C HPUS (0.28 mg)

Pulsatilla 3C HPUS (0.28 mg)

Spongia tosta 3C HPUS (0.28 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredient

croscarmellose sodium, lactose, magnesium stearate

Questions Or Comments? (Questions or comments?)

BoironUSA.com

[email protected]

1-800-BOIRON-1 (1-800-264-7661)



Distributed by Boiron Inc.

Newtown Square, PA 19073

Principle Display Panel Throatcalm (Principle Display Panel - ThroatCalm)


Advanced Ingredient Data


Raw Label Data

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