Allergena Hawaii, Puerto Rico And The Virgin Islands

Allergena Hawaii, Puerto Rico And The Virgin Islands
SPL v1
SPL
SPL Set ID bf625722-f8e2-40b3-b07a-5b3985a93da1
Route
ORAL
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anthoxanthum Odoratum Pollen (30 [hp_X]) Echinacea, Unspecified (3 [hp_X]) Baptisia Tinctoria Root Goldenseal Myrrh Phytolacca Americana Root Fenugreek Leaf Acacia Pollen Alnus Rubra Pollen Alnus Incana Subsp. Rugosa Pollen Fraxinus Velutina Pollen Fraxinus Pennsylvanica Pollen Fraxinus Americana Pollen Morella Cerifera Pollen Eucalyptus Globulus Pollen Prosopis Juliflora Pollen Broussonetia Papyrifera Pollen Morus Rubra Pollen Morus Alba Pollen Quercus Alba Pollen Phoenix Dactylifera Pollen Pinus Strobus Pollen Ligustrum Vulgare Pollen Juglans Nigra Pollen Xanthium Strumarium Pollen Rumex Acetosella Pollen Rumex Crispus Pollen Chenopodium Album Pollen Artemisia Vulgaris Pollen Urtica Dioica Pollen Amaranthus Retroflexus Pollen Amaranthus Spinosus Pollen Plantago Lanceolata Pollen Ambrosia Artemisiifolia Pollen Paspalum Notatum Pollen Cynodon Dactylon Pollen Poa Pratensis Pollen Sorghum Halepense Pollen Dactylis Glomerata Pollen Lolium Perenne Pollen
Inactive Ingredients
Water Alcohol Nasturtium Officinale

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-09-01

Description

Active Ingredients: Antigens 6X, 12X, 30X: **Tropical Tree, **Tropical Weed,**Tropical Grass; Herbal Drainage Remedies 3X: Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum; Echinacea 3X HPUS.


Medication Information

Warnings and Precautions

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctorif symptoms worsen or do not improve after 5 days.
  • If pregnant or breast-feeding, consult a health professional before use.
Indications and Usage

Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*

Dosage and Administration

Directions:•Shake Well Before Use. • Adults (12 and Older)10-15 drops under the tongue three times daily. • Children (2-12) 6-10 drops under the tongue three times daily. • Infants (0-2)3-6 drops under the tongue three times daily or as directed by your health care professional.

Description

Active Ingredients: Antigens 6X, 12X, 30X: **Tropical Tree, **Tropical Weed,**Tropical Grass; Herbal Drainage Remedies 3X: Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum; Echinacea 3X HPUS.

Section 50565-1

Keep Out of Reach of Children.In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6

Inactive Ingredients:Nasturtium aquaticum (watercress), USP Purified Water and 25% USP Ethanol.

Section 51945-4

*www.allergena.com/drugdisclaimer

**Standard antigen mix used in this product is cross-reactive with Tropical Tree, Weed, and Grass allergens. For a complete list of allergens visit

www.allergena.com

Manufactured for PROGENA Professional Formulations

4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

Section 55105-1

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.*

Section 55106-9

Active Ingredients: Antigens 6X, 12X, 30X:**Tropical Tree, **Tropical Weed,**Tropical Grass; Herbal Drainage Remedies 3X:Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum; Echinacea 3X HPUS.

Section 60561-8

Other Information: Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.


Structured Label Content

Indications and Usage (34067-9)

Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*

Dosage and Administration (34068-7)

Directions:•Shake Well Before Use. • Adults (12 and Older)10-15 drops under the tongue three times daily. • Children (2-12) 6-10 drops under the tongue three times daily. • Infants (0-2)3-6 drops under the tongue three times daily or as directed by your health care professional.

Warnings and Precautions (34071-1)

Warnings:

  • Use Only as directed.
  • Stop use and ask a doctorif symptoms worsen or do not improve after 5 days.
  • If pregnant or breast-feeding, consult a health professional before use.
Section 50565-1 (50565-1)

Keep Out of Reach of Children.In case of overdose, get medical help or contact a

Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients:Nasturtium aquaticum (watercress), USP Purified Water and 25% USP Ethanol.

Section 51945-4 (51945-4)

*www.allergena.com/drugdisclaimer

**Standard antigen mix used in this product is cross-reactive with Tropical Tree, Weed, and Grass allergens. For a complete list of allergens visit

www.allergena.com

Manufactured for PROGENA Professional Formulations

4820 Eubank Blvd. NE, ABQ, NM 87111, www.progena.com

Section 55105-1 (55105-1)

Purpose:Relief from Sneezing, Runny Nose, Itchy Eyes and Sinus Congestion.*

Section 55106-9 (55106-9)

Active Ingredients: Antigens 6X, 12X, 30X:**Tropical Tree, **Tropical Weed,**Tropical Grass; Herbal Drainage Remedies 3X:Baptisia tinctoria HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum; Echinacea 3X HPUS.

Section 60561-8 (60561-8)

Other Information: Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.


Advanced Ingredient Data


Raw Label Data

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