SPL v4
SPL
SPL Set ID c3f64a9a-d2e7-4326-aeb0-22c3693f5832
Route
ORAL
Published
Effective Date 2019-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (5 [hp_X]) Apis Mellifera (12 [hp_X]) Aralia Racemosa Root (12 [hp_C]) Blatta Orientalis (3 [hp_X]) Lycoperdon Utriforme Fruiting Body (8 [hp_X]) Milk Thistle Chelidonium Majus Euphrasia Stricta Galphimia Glauca Flowering Top Hedera Helix Flowering Twig Goldenseal Luffa Operculata Fruit Nasturtium Officinale Okoubaka Aubrevillei Bark Schoenocaulon Officinale Seed Scrophularia Nodosa Solidago Virgaurea Flowering Top Taraxacum Officinale
Inactive Ingredients
Alcohol Glycerin Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-06-02

Description

ACTIVE INGERDIENTS (HPUS*): Equal amounts of: Allium Cepa 5X, Apis Mellifica 5X, Aralia Racemosa 5X, Blatta Orientalis 12X, Bovista 12C, Carduus Marianus 3X, Chelidonium Majus 3X, Euphrasia Officinalis 8X, Galphimia Glauca 5X, Hedera Helix 5X, Hydrastis Canadensis 5X, Luffa Operculata 5X, Nasturtium Aquaticum 3X, Okoubaka 5X, Sabadilla 5X, Scrophularia Nodosa 3X, Solidago Virgaurea 5X, Taraxacum Officinale 3X. ​*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Medication Information

Warnings and Precautions

WARNINGS:

KEEP OUT OF THE REACH OF CHILDREN IF PREGNANT OR BREAST - FEEDING, ask a health professional before use. If symptons worsen or persist for more than a week, discontinue use and contact a doctor. Do not use if cap seal is broken.

Indications and Usage

USES: Temporarily relieves coryza, cough and itchy eyes symptoms associated with hay fever and common allergens.**

​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

Dosage and Administration

DIRECTIONS: Shake 10 times before use. Adults & children above 12 years of age: spray 3 - 4 times under the tongue every 15 minutes, extend intervals as symptoms improve or as directed by a health care professional. Children under 12: use half the adults dose. 

Description

ACTIVE INGERDIENTS (HPUS*): Equal amounts of: Allium Cepa 5X, Apis Mellifica 5X, Aralia Racemosa 5X, Blatta Orientalis 12X, Bovista 12C, Carduus Marianus 3X, Chelidonium Majus 3X, Euphrasia Officinalis 8X, Galphimia Glauca 5X, Hedera Helix 5X, Hydrastis Canadensis 5X, Luffa Operculata 5X, Nasturtium Aquaticum 3X, Okoubaka 5X, Sabadilla 5X, Scrophularia Nodosa 3X, Solidago Virgaurea 5X, Taraxacum Officinale 3X. ​*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN

Section 51727-6

INACTIVE INGREDIENTS: Ethanol Alcohol 15%, (non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Vegetable Glycerin 15%, Purified Water.

Section 51945-4

HOMEOPATHIC MEDICINE

NDC: 66096-710-05

ALLERGY

RELIEF

Natural - Safe - Effective

No Side Effects

2 fl oz (59 ml) / 15% Alcohol

Section 55105-1

Natural - Safe - Effective

No Side Effects

Section 55106-9

ACTIVE INGERDIENTS (HPUS*): Equal amounts of: Allium Cepa 5X, Apis Mellifica 5X, Aralia Racemosa 5X, Blatta Orientalis 12X, Bovista 12C, Carduus Marianus 3X, Chelidonium Majus 3X, Euphrasia Officinalis 8X, Galphimia Glauca 5X, Hedera Helix 5X, Hydrastis Canadensis 5X, Luffa Operculata 5X, Nasturtium Aquaticum 3X, Okoubaka 5X, Sabadilla 5X, Scrophularia Nodosa 3X, Solidago Virgaurea 5X, Taraxacum Officinale 3X.

​*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

USES: Temporarily relieves coryza, cough and itchy eyes symptoms associated with hay fever and common allergens.**

​**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

Dosage and Administration (34068-7)

DIRECTIONS: Shake 10 times before use. Adults & children above 12 years of age: spray 3 - 4 times under the tongue every 15 minutes, extend intervals as symptoms improve or as directed by a health care professional. Children under 12: use half the adults dose. 

Warnings and Precautions (34071-1)

WARNINGS:

KEEP OUT OF THE REACH OF CHILDREN IF PREGNANT OR BREAST - FEEDING, ask a health professional before use. If symptons worsen or persist for more than a week, discontinue use and contact a doctor. Do not use if cap seal is broken.

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: Ethanol Alcohol 15%, (non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Vegetable Glycerin 15%, Purified Water.

Section 51945-4 (51945-4)

HOMEOPATHIC MEDICINE

NDC: 66096-710-05

ALLERGY

RELIEF

Natural - Safe - Effective

No Side Effects

2 fl oz (59 ml) / 15% Alcohol

Section 55105-1 (55105-1)

Natural - Safe - Effective

No Side Effects

Section 55106-9 (55106-9)

ACTIVE INGERDIENTS (HPUS*): Equal amounts of: Allium Cepa 5X, Apis Mellifica 5X, Aralia Racemosa 5X, Blatta Orientalis 12X, Bovista 12C, Carduus Marianus 3X, Chelidonium Majus 3X, Euphrasia Officinalis 8X, Galphimia Glauca 5X, Hedera Helix 5X, Hydrastis Canadensis 5X, Luffa Operculata 5X, Nasturtium Aquaticum 3X, Okoubaka 5X, Sabadilla 5X, Scrophularia Nodosa 3X, Solidago Virgaurea 5X, Taraxacum Officinale 3X.

​*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.


Advanced Ingredient Data


Raw Label Data

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