SPL v1
SPL
SPL Set ID 7978fb75-fac9-480d-830c-c8c09ff29be1
Route
ORAL
Published
Effective Date 2019-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anemone Pulsatilla (8 [hp_X]) Onion (6 [hp_X]) Arsenic Cation (3+) Strychnos Nux-vomica Seed Euphrasia Stricta Schoenocaulon Officinale Seed Aralia Racemosa Root Copper
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Acetate Raspberry

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-07-26

Description

Active Ingredients HPUS: Pulsatilla 8X    (Wind flower) Allium cepa 6X (Onion) Arsenicum album 8X    (Arsenous oxide) Nux Vomica 6X    (Poison nut) Euphrasia officinalis 6X    (Eyebright) Sabadilla 6X (Cevadilla) Aralia racemosa 6X (Spikenard) Cuprum metallicum 8X    (Metallic copper)


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.

Indications and Usage

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by sinus symptoms*:



• sneezing

• nasal congestion

• runny nose

• itchy eyes, nose and throat

• watery eyes

• headache

• throat irritation

Dosage and Administration

Directions

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



Children 6 months to 9 years old: 0.5 ml orally every 8 hours or 3 times a day.



Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.



Reduce intake with improvements.



In acute phase only:



Children 2 to 9 years old; Give 1 dropper (0.75ml) at the onset of symptoms. Repeat two more times at intervals of 15 minutes.



Repeat this procedure up to 6 times per day if symptoms reoccur, or as directed by a healthcare practitioner.



Not to be taken with meals

Description

Active Ingredients HPUS: Pulsatilla 8X    (Wind flower) Allium cepa 6X (Onion) Arsenicum album 8X    (Arsenous oxide) Nux Vomica 6X    (Poison nut) Euphrasia officinalis 6X    (Eyebright) Sabadilla 6X (Cevadilla) Aralia racemosa 6X (Spikenard) Cuprum metallicum 8X    (Metallic copper)

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, raspberry flavour.

Section 55105-1

Purpose

Sinus symptoms, sneezing, nasal congestion, runny nose, itchy eyes, nose and throat, watery eyes headache, throat 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:

Pulsatilla 8X

   (Wind flower)

Allium cepa 6X (Onion)

Arsenicum album 8X

   (Arsenous oxide)

Nux Vomica 6X

   (Poison nut)

Euphrasia officinalis 6X

   (Eyebright)

Sabadilla 6X (Cevadilla)

Aralia racemosa 6X (Spikenard)

Cuprum metallicum 8X

   (Metallic copper)

Kids Relief Sinus Oral Liquid


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by sinus symptoms*:



• sneezing

• nasal congestion

• runny nose

• itchy eyes, nose and throat

• watery eyes

• headache

• throat 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 9 years old: 0.5 ml orally every 8 hours or 3 times a day.



Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.



Reduce intake with improvements.



In acute phase only:



Children 2 to 9 years old; Give 1 dropper (0.75ml) at the onset of symptoms. Repeat two more times at intervals of 15 minutes.



Repeat this procedure up to 6 times per day if symptoms reoccur, or as directed by a healthcare practitioner.



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.

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, raspberry flavour.

Section 55105-1 (55105-1)

Purpose

Sinus symptoms, sneezing, nasal congestion, runny nose, itchy eyes, nose and throat, watery eyes headache, throat 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:

Pulsatilla 8X

   (Wind flower)

Allium cepa 6X (Onion)

Arsenicum album 8X

   (Arsenous oxide)

Nux Vomica 6X

   (Poison nut)

Euphrasia officinalis 6X

   (Eyebright)

Sabadilla 6X (Cevadilla)

Aralia racemosa 6X (Spikenard)

Cuprum metallicum 8X

   (Metallic copper)

Kids Relief Sinus Oral Liquid


Advanced Ingredient Data


Raw Label Data

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