SPL v1
SPL
SPL Set ID c0963200-67dd-6349-e053-2a95a90adde1
Route
ORAL
Published
Effective Date 2021-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-06-01

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


Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and Administration
  • 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

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

Section 50565-1

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.

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53413-1

Questions or Comments?

Call us at 1-855-366-7755 (U.S.A only)

M-F 8am-5pm CST

Section 53414-9

If pregnant or breastfeeding, consult your doctor before use.

Section 55105-1

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

Section 55106-9

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


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)
  • 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

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

Call us at 1-855-366-7755 (U.S.A only)

M-F 8am-5pm CST

Section 53414-9 (53414-9)

If pregnant or breastfeeding, consult your doctor before use.

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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


Advanced Ingredient Data


Raw Label Data

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