SPL v3
SPL
SPL Set ID 91c2795d-4cde-6e2c-e053-2995a90a0096
Route
ORAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aralia Racemosa Root (12 [hp_X]) Galphimia Glauca Flowering Top (6 [hp_X]) Luffa Operculata Fruit Euphrasia Stricta Histamine Anemone Pulsatilla Onion Sodium Cation Solidago Virgaurea Flowering Top
Inactive Ingredients
Potassium Sorbate Glycerin Water Citric Acid Monohydrate Concord Grape Juice

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-07-20

Description

Active Ingredients Allium cepa 12X HPUS Aralia racemosa 12X HPUS Euphrasia officinalis 12X HPUS Galphimia glauca 12X HPUS Histaminum hydrochloricum 12X HPUS Luffa operaculata 12X HPUS Pulsatilla 12X HPUS Solidago 12X HPUS Cell Salts Natrum muriaticum 6X HPUS

Purpose

Purpose Hay fever, watery eyes Watery irritating nasal discharge Eye irritation, watery eyes Sneezing, runny nose Hay fever, mild wheezing Acute rhinitis Sinus pain Nasal discharge Sneezing, itchy eyes


Medication Information

Purpose

Purpose

Hay fever, watery eyes

Watery irritating nasal discharge

Eye irritation, watery eyes

Sneezing, runny nose

Hay fever, mild wheezing

Acute rhinitis

Sinus pain

Nasal discharge

Sneezing, itchy eyes

Description

Active Ingredients Allium cepa 12X HPUS Aralia racemosa 12X HPUS Euphrasia officinalis 12X HPUS Galphimia glauca 12X HPUS Histaminum hydrochloricum 12X HPUS Luffa operaculata 12X HPUS Pulsatilla 12X HPUS Solidago 12X HPUS Cell Salts Natrum muriaticum 6X HPUS

Uses

Uses

Temporarily relieves the symptoms associated with hay fever or other upper respiratory allergies, such as

  • sneezing
  • sinus pain
  • runny nose
  • watery eyes
  • mild wheezing
  • itchy nose and throat

Warnings

Warnings

Do not use:

  • to treat food allergies
  • for persistent or chronic cough
  • for treating cough from asthma, smoking, or emphysema
  • for treating cough with excessive mucus

A persistent cough may be a sign of a serious condition

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Directions
  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Active Ingredients

Active Ingredients

Allium cepa 12X HPUS

Aralia racemosa 12X HPUS

Euphrasia officinalis 12X HPUS

Galphimia glauca 12X HPUS

Histaminum hydrochloricum 12X HPUS

Luffa operaculata 12X HPUS

Pulsatilla 12X HPUS

Solidago 12X HPUS

Cell Salts

Natrum muriaticum 6X HPUS

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Principal Display Panel

Pregnancy Or Breastfeeding

If pregnant or breastfeeding, consult your doctor before use.

Keep Out of Reach of Children

Keep out of reach of children. in case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.


Structured Label Content

Uses

Uses

Temporarily relieves the symptoms associated with hay fever or other upper respiratory allergies, such as

  • sneezing
  • sinus pain
  • runny nose
  • watery eyes
  • mild wheezing
  • itchy nose and throat

Purpose

Purpose

Hay fever, watery eyes

Watery irritating nasal discharge

Eye irritation, watery eyes

Sneezing, runny nose

Hay fever, mild wheezing

Acute rhinitis

Sinus pain

Nasal discharge

Sneezing, itchy eyes

Warnings

Warnings

Do not use:

  • to treat food allergies
  • for persistent or chronic cough
  • for treating cough from asthma, smoking, or emphysema
  • for treating cough with excessive mucus

A persistent cough may be a sign of a serious condition

Questions

Questions or Comments?

Call us at 1-800-588-6227

M-F 8am-5pm CST

Directions
  • Shake before use, natural juice may settle
  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, weight is specific to product
  • On dosing syringe, ml = milliliter, lbs = pounds, kgs = kilograms

Children under 6 months of age, consult a medical professional before using this product.

For sudden onset of symptoms: Use every 15 minutes for up to 8 doses until symptoms relieved, then every 2 hours thereafter.

Children 6 - 18 lbs or 3 - 8 kgs

1.25 ml every 2 hours, reduce frequency when symptoms improve

Children 19 - 29 lbs or 9 - 13 kgs

2.5 ml every 2 hours, reduce frequency when symptoms improve

Children 30 - 90 lbs or 14 - 41 kgs

5 ml every 2 hours, reduce frequency when symptoms improve

Active Ingredients

Active Ingredients

Allium cepa 12X HPUS

Aralia racemosa 12X HPUS

Euphrasia officinalis 12X HPUS

Galphimia glauca 12X HPUS

Histaminum hydrochloricum 12X HPUS

Luffa operaculata 12X HPUS

Pulsatilla 12X HPUS

Solidago 12X HPUS

Cell Salts

Natrum muriaticum 6X HPUS

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium sorbate, purified water

Principal Display Panel

Pregnancy Or Breastfeeding (Pregnancy or breastfeeding)

If pregnant or breastfeeding, consult your doctor before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. in case of overdoes (or accidental ingestion), get medical help or contact a Poison Control Center right away. DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.


Advanced Ingredient Data


Raw Label Data

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