SPL v1
SPL
SPL Set ID 18a6f6d4-cdfd-4bf7-8cb2-831033c1d965
Route
ORAL
Published
Effective Date 2019-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (8 [hp_X]) Phosphate Ion Mercurius Solubilis Sodium Sulfate Anhydrous Calcium Sulfide Arisaema Triphyllum Root
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate Caramel

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-08-01

Description

Active Ingredients HPUS : Arsenicum Album (Arsenous Oxide) 8X  Kali Phosphoricum (Dipotassium phosphate) 8X  Mercuris Solubilis (Hahnemann’s soluble mercury) 8X  Natrum Sulphuricum (Disodium sulfate) 8X  Hepar Sulphuris Calcareum (Liver of sulfur) 8X  Arum Triphyllum (Indian turnip) 8X 


Medication Information

Warnings and Precautions

Warnings

Do not use if seal is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Keep out of reach of children.

Indications and Usage

Uses :



This homeopathic medicine to help relieve sore throat symptoms:

• burning pain

• inflammation

• difficulty to swallow

• hoarseness

• irritation

Dosage and Administration

Directions

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.



Children 6 months to 6 years old: ½ a teaspoon (2.5 ml) orally every 8 hours or 3 times a day.



Children 7 to 12 years old: 1 teaspoon (5.0 ml) orally every 8 hours or 3 times a day.



Reduce intake with improvements.



Not to be taken with meals

Description

Active Ingredients HPUS : Arsenicum Album (Arsenous Oxide) 8X  Kali Phosphoricum (Dipotassium phosphate) 8X  Mercuris Solubilis (Hahnemann’s soluble mercury) 8X  Natrum Sulphuricum (Disodium sulfate) 8X  Hepar Sulphuris Calcareum (Liver of sulfur) 8X  Arum Triphyllum (Indian turnip) 8X 

Section 44425-7

Other information

•Store at room temperature

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, caramel.

Section 55105-1

Purpose :

Homeopathic remedy helps relieve symptoms of sore throat, burning pain, inflammation (mucus), difficulty to swallow, hoarseness and irritation.



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



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated

Section 55106-9

Active Ingredients HPUS:

Arsenicum Album (Arsenous Oxide) 8X 



Kali Phosphoricum (Dipotassium phosphate) 8X 



Mercuris Solubilis (Hahnemann’s soluble mercury) 8X 



Natrum Sulphuricum (Disodium sulfate) 8X 



Hepar Sulphuris Calcareum (Liver of sulfur) 8X 



Arum Triphyllum (Indian turnip) 8X 

Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses :



This homeopathic medicine to help relieve sore throat symptoms:

• burning pain

• inflammation

• difficulty to swallow

• hoarseness

• irritation

Dosage and Administration (34068-7)

Directions

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.



Children 6 months to 6 years old: ½ a teaspoon (2.5 ml) orally every 8 hours or 3 times a day.



Children 7 to 12 years old: 1 teaspoon (5.0 ml) orally every 8 hours or 3 times a day.



Reduce intake with improvements.



Not to be taken with meals

Warnings and Precautions (34071-1)

Warnings

Do not use if seal is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Keep out of reach of children.

Section 44425-7 (44425-7)

Other information

•Store at room temperature

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, caramel.

Section 55105-1 (55105-1)

Purpose :

Homeopathic remedy helps relieve symptoms of sore throat, burning pain, inflammation (mucus), difficulty to swallow, hoarseness and irritation.



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



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Arsenicum Album (Arsenous Oxide) 8X 



Kali Phosphoricum (Dipotassium phosphate) 8X 



Mercuris Solubilis (Hahnemann’s soluble mercury) 8X 



Natrum Sulphuricum (Disodium sulfate) 8X 



Hepar Sulphuris Calcareum (Liver of sulfur) 8X 



Arum Triphyllum (Indian turnip) 8X 

Principal Display Panel (Principal display panel)


Advanced Ingredient Data


Raw Label Data

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