Throatcalm Pellets

Throatcalm Pellets
SPL v2
SPL
SPL Set ID de97d002-de84-bcef-e053-2995a90a319b
Route
ORAL
Published
Effective Date 2022-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arisaema Triphyllum Root (3 [hp_C]) Atropa Belladonna (4 [hp_C]) Mercurius Solubilis Bromine Bryonia Alba Root Spongia Officinalis Skeleton, Roasted Phytolacca Americana Root Pulsatilla Vulgaris Arnica Montana
Inactive Ingredients
Lactose, Unspecified Form Sucrose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-05-09

Description

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.


Medication Information

Indications and Usage

Uses*

temporarily relieves minor sore throat and hoarseness

Dosage and 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.
Description

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.

Section 42229-5
  • 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.

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 50566-9

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

Section 50569-3

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.
Section 51727-6

lactose, sucrose

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA 19073

Section 53414-9

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

Section 55105-1

Purpose*

Relieves Sore Throat Symptoms: Red and Dry Throat, Raw Sore Throat, Hoarseness, Swollen Tonsils

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves minor sore throat and hoarseness

Dosage and Administration (34068-7)
  • 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.
Section 42229-5 (42229-5)
  • 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.

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 50566-9 (50566-9)

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

Section 50569-3 (50569-3)

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.
Section 51727-6 (51727-6)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-264-7661

Made in France

Distributed by

Boiron Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Relieves Sore Throat Symptoms: Red and Dry Throat, Raw Sore Throat, Hoarseness, Swollen Tonsils

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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