SPL v1
SPL
SPL Set ID e8bdcc8a-c947-ff5d-e053-2a95a90a3b92
Route
ORAL
Published
Effective Date 2022-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-12

Description

Active ingredients (HPUS) Allium cepa 12X Aralia racemosa 12X Euphrasia officinalis 12X. Galphimia glauca 12X Histaminum hydrochloricum 12X Luffa operculata 12X Pulsatilla 12X Solidago 12X CELL SALTS Natrum muriaticum 6X

Purpose

Temporarily Relieves: Hay Fever Sneezing Mild wheezing Itchy Nose, Thorat, & Watery Eyes Runny & Stuffy Nose


Medication Information

Purpose

Temporarily Relieves:

  • Hay Fever
  • Sneezing
  • Mild wheezing
  • Itchy Nose, Thorat, & Watery Eyes
  • Runny & Stuffy Nose
Description

Active ingredients (HPUS) Allium cepa 12X Aralia racemosa 12X Euphrasia officinalis 12X. Galphimia glauca 12X Histaminum hydrochloricum 12X Luffa operculata 12X Pulsatilla 12X Solidago 12X CELL SALTS Natrum muriaticum 6X

Uses

Temporrarily relieves the symptoms asscociated with hay fever or other upper respiratory allergies, such as

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

Pregnancy

If pregnant or breastfeeding, consult your doctor before use.

Keep out of reach of children.

Questions

Questions or comments?

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

M-F 8am-5pm CST

Directions

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 kg

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

Ask A Doctor

Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.

Please consult your physician immidiately for a worsening condition.

Principal Display

PRINCIPAL DISPLAY

Active Ingredients

Active ingredients (HPUS)

Allium cepa 12X

Aralia racemosa 12X

Euphrasia officinalis 12X.

Galphimia glauca 12X

Histaminum hydrochloricum 12X

Luffa operculata 12X

Pulsatilla 12X

Solidago 12X

CELL SALTS

Natrum muriaticum 6X

Inactive Ingredients

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

Keep Out of Reach of Children

Keep out of reach of children.

In case of overdose (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

Temporrarily relieves the symptoms asscociated with hay fever or other upper respiratory allergies, such as

  • itchy nose and throat
  • watery eyes
  • runny nose
  • sneezing
  • sinus pain
  • mild wheezing
Purpose (PURPOSE)

Temporarily Relieves:

  • Hay Fever
  • Sneezing
  • Mild wheezing
  • Itchy Nose, Thorat, & Watery Eyes
  • Runny & Stuffy Nose
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.

Pregnancy (PREGNANCY)

If pregnant or breastfeeding, consult your doctor before use.

Keep out of reach of children.

Questions (QUESTIONS)

Questions or comments?

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

M-F 8am-5pm CST

Directions (DIRECTIONS)

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 kg

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

Ask A Doctor (ASK A DOCTOR)

Ask a doctor before use if you are taking a prescription drug or have a serious medical condition.

Please consult your physician immidiately for a worsening condition.

Principal Display (PRINCIPAL DISPLAY)

PRINCIPAL DISPLAY

Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients (HPUS)

Allium cepa 12X

Aralia racemosa 12X

Euphrasia officinalis 12X.

Galphimia glauca 12X

Histaminum hydrochloricum 12X

Luffa operculata 12X

Pulsatilla 12X

Solidago 12X

CELL SALTS

Natrum muriaticum 6X

Inactive Ingredients (INACTIVE INGREDIENTS)

Inactive ingredients

Citric acid, glycerin, grape juice, potassium

sorbate, purified water

Keep Out of Reach of Children

Keep out of reach of children.

In case of overdose (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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